MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-13 for ENDOPATH LINEAR CUTTER EUC35 manufactured by Ethicon Endo-surgery.
[8618]
Linear cutter malfunctioned and ceased to cut tissue even after multiple attempts. Handle finally broke in surgeon's hand. Laparoscopic assisted vaginal hysterectomy was turned into total abdominal hysterectomy because of excessive bleeding. No adverse outcome to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001194 |
| MDR Report Key | 12234 |
| Date Received | 1994-03-24 |
| Date of Report | 1994-03-21 |
| Date of Event | 1994-03-17 |
| Date Added to Maude | 1994-03-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH LINEAR CUTTER |
| Generic Name | LINEAR CUTTER WITH SAFETY LOCK-OUT, STAPLER |
| Product Code | HBS |
| Date Received | 1996-05-13 |
| Catalog Number | EUC35 |
| Lot Number | EMOG3LY |
| Device Expiration Date | 1998-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12234 |
| Manufacturer | ETHICON ENDO-SURGERY |
| Manufacturer Address | CINCINNATI OH 452422839 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-03-24 |