MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,08 report with the FDA on 2014-11-13 for TENOTOMY SCISSOR DO250R manufactured by Aesclap.
[5292288]
While using the tenotomy scissor during a podiatry procedure, the tip of one of the scissor blades broke off and it was believed to have fallen on the floor. After the procedure was completed, an x-ray was performed to confirm that the tip was not in the pt or surgical incision. There was no injury to the pt or user and no additional medical intervention or medicine due to the incident was required.
Patient Sequence No: 1, Text Type: D, B5
[12628338]
Defective device was sent to oem for comprehensive investigation on 10/15/2014 under the return authorization # (b)(4). We were notified on 11/12/2014 that the actual device was sent to aesculap ((b)(4)) for detailed investigation. Investigational results have not been provided as of today.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1055892-2014-00001 |
| MDR Report Key | 4369877 |
| Report Source | 00,08 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-11-13 |
| Date of Event | 2014-10-09 |
| Date Mfgr Received | 2014-10-13 |
| Date Added to Maude | 2015-01-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ASTRID HUDSON |
| Manufacturer Street | 1416 DOGWOOD WAY |
| Manufacturer City | MEBANE NC 27302 |
| Manufacturer Country | US |
| Manufacturer Postal | 27302 |
| Manufacturer Phone | 9195638555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TENOTOMY SCISSOR |
| Generic Name | TENOTOMY SCISSOR |
| Product Code | HRR |
| Date Received | 2014-11-13 |
| Returned To Mfg | 2014-10-15 |
| Model Number | DO250R |
| Catalog Number | DO250R |
| Lot Number | 714887001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCLAP |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-13 |