MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-01 for PROXIMATE RELOADABLE LINEAR CUTTER TLC7S manufactured by Ethicon Endosurgery Johnson & Johnson.
[9902]
On 2/24/94, patient underwent small bowel resection with anastomosis. Patient had to return to surgery on 2/26/94 due to complications and it was noted there were no staples around the area of the anastomosis. Stapling device was suspected to be defective, but since it was a disposable device, this cannot be verified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 18595 |
| MDR Report Key | 18595 |
| Date Received | 1994-08-01 |
| Date of Report | 1994-04-22 |
| Date of Event | 1994-02-26 |
| Date Added to Maude | 1994-12-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | PROXIMATE RELOADABLE LINEAR CUTTER |
| Generic Name | DISPOSABLE STAPLER |
| Product Code | HBS |
| Date Received | 1994-08-01 |
| Model Number | TLC7S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18523 |
| Manufacturer | ETHICON ENDOSURGERY JOHNSON & JOHNSON |
| Manufacturer Address | 4545 CREEK RD. CINCINNATI OH 452422803 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-08-01 |