MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-30 for GIA 100-4.8 SINGLE USE LOADING UNIT GIA10048L manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[56547889]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[56547890]
According to the reporter, during a laparoscopy, with a successful first firing attempt, an additional reload but, once, fired, there was staple line bleeding where the staples did not form properly. Hemostasis was achieved by ligating with a manual suture. There was no further effect to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[58749810]
Patient Sequence No: 1, Text Type: N, H10
[58749811]
According to the reporter: to fix the incomplete staple line it was over sewed. The last known patient status is stable.
Patient Sequence No: 1, Text Type: D, B5
[59391918]
(b)(4). Post market vigilance (pmv) led an evaluation of one stapler opened by the account. This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device. The visual inspection of the instrument displayed no abnormalities. Further visual inspection of the cartridge noted that the single use loading unit (sulu) was fully applied. Additionally, microscopic inspection of the knife blade displayed no damage. The sulu was reset, reloaded with staples, and reloaded into the instrument. The sulu and instrument were applied to test media with acceptable results; the knife cut completely and cleanly and the staple line was properly formed. Visual and functional testing of the returned sample confirmed the product met quality release specifications that were tested. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. The file will be closed as fired satisfactorily as the device was found to meet all visual and functional test specifications. Should new information become available, the file will be re-opened and reassessed as necessary. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2016-00782 |
| MDR Report Key | 5991761 |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-09-07 |
| Date Mfgr Received | 2016-10-25 |
| Date Added to Maude | 2016-09-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| 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 100-4.8 SINGLE USE LOADING UNIT |
| Generic Name | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
| Product Code | FHM |
| Date Received | 2016-09-30 |
| Model Number | GIA10048L |
| Catalog Number | GIA10048L |
| Lot Number | P5K0445KLX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Address | BUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE PR 00731 US 00731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-30 |