MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-03 for DOUBLEAIRHOSE L5M F/SYST SYNTHES 519.530 manufactured by Umkirch.
[78910603]
(b)(4). (b)(6). This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the reported condition was confirmed. 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 will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[78910604]
It was reported from (b)(6) that during service and evaluation, it was determined that the air hose device had general wear and an exploded sheath. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2017-13396 |
| MDR Report Key | 6683838 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-03 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-15 |
| Device Manufacturer Date | 2014-05-08 |
| Date Added to Maude | 2017-07-03 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| 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, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-07-03 |
| Returned To Mfg | 2017-06-15 |
| Catalog Number | 519.530 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-07-03 |