MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-11-03 for TA 90 B REUSABLE INSTRUMENT 010884 manufactured by United States Surgical.
[2353857]
Procedure type: gastric bypass. According to the reporter: the stapler malfunctioned while firing the cartridge. The staples did not fire properly. The stapler now does not load properly nor fire accurately as it deflects the anvil. This happened twice with both units. The units feel flimsy and metal work is not parallel according to the reporter. The pt is fine. Tissue damage to the gastric pouch occurred; however, it was corrected by reapplication when another device was opened and re-applied.
Patient Sequence No: 1, Text Type: D, B5
[9467300]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2011-00967 |
| MDR Report Key | 2338072 |
| Report Source | 01,05,06 |
| Date Received | 2011-11-03 |
| Date of Report | 2011-11-01 |
| Date of Event | 2011-08-31 |
| Date Mfgr Received | 2011-11-01 |
| Date Added to Maude | 2011-11-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926273 |
| Manufacturer Street | 195 MCDERMOTT RD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TA 90 B REUSABLE INSTRUMENT |
| Generic Name | DISPOSABLE SURGICAL STAPLING DEVICE |
| Product Code | FHM |
| Date Received | 2011-11-03 |
| Catalog Number | 010884 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES SURGICAL |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-11-03 |