MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-15 for SURGAIRTOME TWO HANDPIECE 00505800100 manufactured by Conmed Corporation.
[127213761]
Evaluation found collet bearings worn. Ran unit for 1 min out of a 3 min run test and the temp was 149deg. Maximum temperature should be 110? F. Last preventive maintenance was performed 04/09/18 and the collet assembly was replaced, however, device was used in the field for over 6 months with an unknown number of uses. Previous history shows repeated failure due to corrosion and lack of consistency in compliance to preventive maintenance schedule. A two-year review of complaint history revealed there has been a total of 33 complaints, regarding 33 devices, for this device family and failure mode. During this same time frame (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4). Per the instructions for use, the user is advised the following: warnings and precautions: regular service is required to keep the surgairtome two handpiece at its optimum operating performance. Warnings: prior to each use, inspect all equipment for proper operation. Continually check all handpieces and attachments for overheating. If overheating is sensed, immediately discontinue use and return the equipment for service. Overheating of the bur or bit may cause damage to the bur or bit and may cause burns or thermal necrosis. Failure to follow the maintenance schedule... Could result in reduced instrument performance or overheating of the handpiece or attachment. Overheating can lead to possible burn injury to the patient or medical personnel. Rotation of handpiece usage per day will assist with proper performance. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[127213762]
The customer reported that 00505800100, surgairtome two handpiece, device got hot at the burguard and slightly burned the patients cheek during an apicoectomy on (b)(6) 2018. The procedure was completed with another device and there was no delay or cancellation of the procedure. The patient then saw a dermatologist later and was given a prescription for the burn. This report is being raised on the basis of injury due to the patient receiving a burn that required medical intervention by prescription.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2018-00171 |
| MDR Report Key | 8073145 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 2001-12-04 |
| Date Added to Maude | 2018-11-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGAIRTOME TWO HANDPIECE |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2018-11-15 |
| Returned To Mfg | 2018-11-13 |
| Catalog Number | 00505800100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-15 |