MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-13 for L-CLIP APPL/REMVR 90 MM RND HANDLE VAR 45.441 manufactured by The Anspach Effort, Inc..
[3192390]
Report received from the usa stating that there was a "loss of tension" being experienced in the device and "would not release the aneurysm clip during surgery. " there was a five minute delay in surgery to remove the clip and place it onto a new applier. The new applier was no malleable. The outcome of the surgery was good; clipped the aneurysm without a problem. There were no injuries or medical intervention reported. There was no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[10543497]
The device has been received by anspach. If additional information is received, a supplemental report will be sent. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045834-2013-00644 |
| MDR Report Key | 3008555 |
| Report Source | 06 |
| Date Received | 2013-03-13 |
| Date of Report | 2013-02-12 |
| Date of Event | 2013-02-08 |
| Date Mfgr Received | 2013-02-12 |
| Date Added to Maude | 2013-05-16 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUZANNE GOODMAN |
| Manufacturer Street | 4500 RIVERSIDE DR. |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5614943706 |
| 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 |
| Product Code | HCI |
| Date Received | 2013-03-13 |
| Catalog Number | 45.441 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE ANSPACH EFFORT, INC. |
| Manufacturer Address | PALM BEACH GARDENS FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-13 |