FDA Adverse Event
Injury
Summary report: N
MULTIFIRE ENDO GIA* 30-3.5 12MM STAPLER
MDR report key: 4965171
·
Received August 4, 2015
Report
- Report Number
- 2647580-2015-00559
- Event Type
- Injury
- Date Received
- August 4, 2015
- Report Date
- July 17, 2015
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO INC
- Product Code
- GDW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN PERFORMED. THIS REVIEW CONFIRMED THAT THIS LOT OF PRODUCTS WAS REVIEWED AND RELEASED ACCORDING TO QA SPECIFICATIONS. A REVIEW OF HISTORICAL COMPLAINT DATA DISPLAYED NO INCREASE IN TRENDS.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE WAS COMPLETED WITH 030813. THE PATIENT GOT POST OPERATIVE BLEEDINGS. THERE HAD TO BE A REOPERATION. BLEEDING CAME STRAIGHT OUT OF CLAMP SUTURE ROW. BLEEDING WAS STOPPED. MORE DETAILS WILL BE PROVIDED SOON. INSTRUMENT PART OF A KIT: ITEM CODE KIT-DE-0094 LOT P5C0818X
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 506160 | MULTIFIRE ENDO GIA* 30-3.5 12MM STAPLER | DSIPOSABLE STAPLER | GDW | COVIDIEN, FORMERLY USSC PUERTO RICO INC | 030813 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |