MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for ENDOPATH, ENDOSCOPIC RELOADABLE LINEAR CUTT EUC35 manufactured by Ethicon, Johnson & Johnson.
[10142]
Linear cutter malfunctioned and ceased to cut tissue even after multiple attempts. Handle finally broke in surgeon's hand. Laparoscopic assisted vag. Hyst was turned into total abd. Hysterectomy because of excessive bleeding. Unplanned procedure. No adverse outcome to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17324 |
| MDR Report Key | 17324 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-06-21 |
| Date of Event | 1994-03-17 |
| Date Added to Maude | 1994-11-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH, ENDOSCOPIC RELOADABLE LINEAR CUTT |
| Generic Name | LINEAR CUTTER W/SAFETY LOCK-OUT. STAPLER |
| Product Code | HBS |
| Date Received | 1994-07-21 |
| Model Number | EUC35 |
| Catalog Number | EUC35 |
| Lot Number | EMOG3LY |
| Device Expiration Date | 1998-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12234 |
| Manufacturer | ETHICON, JOHNSON & JOHNSON |
| Manufacturer Address | SUMMERVILLE NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-07-21 |