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 2017-10-16 for DOUBLEAIRHOSE L3M F/SYST-SYNTHES 519.510 manufactured by Umkirch.
[90081051]
(b)(4). Reporter? S full name and complete address were not provided. (b)(6). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[90081052]
It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the double air hose device pipe was leaking out of the sheath. It was not reported that this event occurred prior to the procedure and a spare device was available to complete the surgery. There was patient involvement. There were no injuries, medical intervention or prolonged hospitalization. The exact date of this event was unknown. 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 | 8030965-2017-15484 |
| MDR Report Key | 6950843 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-16 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2014-10-29 |
| Date Added to Maude | 2017-10-16 |
| 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 L3M F/SYST-SYNTHES |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-10-16 |
| Catalog Number | 519.510 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-16 |