MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for DOUBLEAIRHOSE L5M F/SYST SYNTHES 519.530 manufactured by Umkirch.
[59622943]
(b)(4). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[59622944]
This is report 2 of 3 for the same event. It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the double air-hose device was leaking. It was reported that the same event occurred with three hose devices in the same procedure. It was not reported if there were any delays in a surgical procedure or if a spare device was available. There was patient involvement reported. There were no patient or user injuries reported. It was reported there was no medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[68492081]
Additional information: the initial medwatch report stated that three products were involved in the same event. During subsequent follow-up with the reporter, additional information was obtained. The reporter stated that there were four products used in the same procedure. Therefore, this report represents 2 of 4 products for the same event. Device evaluation: the actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition of an air hose leak was confirmed. An assessment was performed on the device which determined the unit was generally broken, torn off. It was noted that the device was physically broken. The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2016-15418 |
| MDR Report Key | 6089600 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-10-14 |
| Date of Event | 2016-10-13 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2014-10-13 |
| Date Added to Maude | 2016-11-09 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | UMKIRCH |
| Manufacturer Street | IM KIRCHENHURSTLE 4 |
| Manufacturer City | UMKIRCH B. FREIBURG D-79224 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79224 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLEAIRHOSE L5M F/SYST SYNTHES |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2016-11-09 |
| Returned To Mfg | 2017-02-08 |
| Catalog Number | 519.530 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UMKIRCH |
| Manufacturer Address | IM KIRCHENHURSTLE 4 UMKIRCH B. FREIBURG D-79224 GM D-79224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-09 |