MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-10-23 for L-CLIP APPL/REMVR 90 MM RND HANDLE VAR 45.441 manufactured by Depuy Synthes Power Tools.
[3794149]
It was reported that the applier device "would not hold the aneurysm clip". It was unknown to the reporter if the device was used in surgery.? It was unknown to the reporter if there were any delays in a surgical procedure or if a spare device was available.? It was unknown if injuries or medical intervention were reported. The exact date of the event was unknown. 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
[11398144]
This device is not manufactured by company, 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
| Report Number | 1045834-2013-29282 |
| MDR Report Key | 3425547 |
| Report Source | 06,07 |
| Date Received | 2013-10-23 |
| Date of Report | 2013-09-27 |
| Date Mfgr Received | 2013-09-27 |
| Date Added to Maude | 2014-01-24 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. RODNEY CRAIN |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5616271080 |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L-CLIP APPL/REMVR 90 MM RND HANDLE VAR |
| Generic Name | NI |
| Product Code | HCI |
| Date Received | 2013-10-23 |
| Catalog Number | 45.441 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-23 |