MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-09 for L-CLIP APPL/REMVR 90 MM RND HANDLE VAR 45.441 manufactured by The Anspach Effort, Inc..
[18624738]
Report received from the usa stating that the device? Sticks even after cleaning and flushing the instrument.? The event occurred during an aneurysm surgery. There were no injuries reported. There was no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[18752534]
The device has not been received by anspach. If additional information is received, a supplemental report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045834-2013-00067 |
| MDR Report Key | 2915396 |
| Report Source | 06 |
| Date Received | 2013-01-09 |
| Date of Report | 2012-12-10 |
| Date of Event | 2012-12-07 |
| Report Date | 2012-12-10 |
| Date Mfgr Received | 2012-12-10 |
| Date Added to Maude | 2013-04-01 |
| 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 | 3 |
| 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 | 3 |
| 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 | 2013-01-09 |
| 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 | 2013-01-09 |