MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for CAPTURA G56076 DBF-2.4SL-230SP-40-S manufactured by Wilson-cook Medical Inc..
[121453962]
The tip of the forceps were found loose and separated from the body when the device was tested to open and close before loading the scope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7901401 |
| MDR Report Key | 7901401 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-09-07 |
| Report Date | 2018-09-17 |
| Date Reported to FDA | 2018-09-17 |
| Date Reported to Mfgr | 2018-09-24 |
| Date Added to Maude | 2018-09-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURA |
| Generic Name | FORCEPS, BIOPSY, ELECTRIC |
| Product Code | KGE |
| Date Received | 2018-09-24 |
| Model Number | G56076 |
| Catalog Number | DBF-2.4SL-230SP-40-S |
| Lot Number | W4096751 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILSON-COOK MEDICAL INC. |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-24 |