MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-18 for L-CLIP APPL/REMVR 90 MM RND HANDLE VAR 45.441 manufactured by Peter Lazic Gmbh.
[19721695]
Report received from the usa stating that "after applying two clips, the applier would not grab the third clip during an aneurysm surgery". No injury or medical intervention occurred. There was no add'l info provided.
Patient Sequence No: 1, Text Type: D, B5
[19821759]
The device was received by anspach. Anspach is the importer of the device. If add'l info is received, a supplemental report will be sent. Ref: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045834-2013-14846 |
| MDR Report Key | 3994542 |
| Date Received | 2013-12-18 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-09-21 |
| Date Facility Aware | 2012-10-03 |
| Report Date | 2012-10-03 |
| Date Added to Maude | 2014-08-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 4500 RIVERSIDE DR. |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer G1 | THE ANSPACH EFFORT, INC. |
| Manufacturer Street | 4500 RIVERSIDE DR. |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| 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 | NONE |
| Product Code | HCI |
| Date Received | 2013-12-18 |
| Catalog Number | 45.441 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PETER LAZIC GMBH |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-18 |