MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2010-09-28 for GIA 90 PREMIUM STAINLESS STEEL DLU 030735L manufactured by Ussc Puerto Rico.
[1662926]
Procedure type: hemi colectomy. According to the rptr: during the case, device did not fire correctly. The staples were malformed and some fell into the cavity, they were retrieved by suction and irrigation procedure. A new stapler was used and suturing to complete the case. There was no additional bleeding, but operating room time was extended over 30 mins and hospital stay was prolonged. The pt is fine; discharged from hospital.
Patient Sequence No: 1, Text Type: D, B5
[8702034]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2010-00789 |
| MDR Report Key | 1849497 |
| Report Source | 01,06 |
| Date Received | 2010-09-28 |
| Date of Report | 2010-09-02 |
| Date of Event | 2010-08-23 |
| Date Mfgr Received | 2010-09-02 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2010-10-05 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926273 |
| Manufacturer G1 | USSC PUERTO RICO |
| Manufacturer Street | BUILDING 911-67 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 00731 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00731 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIA 90 PREMIUM STAINLESS STEEL DLU |
| Generic Name | DISPOSABLE SURGICAL STAPLER |
| Product Code | FHM |
| Date Received | 2010-09-28 |
| Returned To Mfg | 2010-09-14 |
| Catalog Number | 030735L |
| Lot Number | P8B0626 |
| Device Expiration Date | 2013-02-28 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | USSC PUERTO RICO |
| Manufacturer Address | BUILDING 911-67 PONCE PR 00731 US 00731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-28 |