FDA Adverse Event
Injury
Summary report: N
GIA UNIVERSAL
MDR report key: 2170070
·
Received July 13, 2011
Report
- Report Number
- 2647580-2011-00463
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 3, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS. ACCORDING TO THE REPORTER: ON THE 3RD ANASTOMOSIS, THE KNIFE WAS STUCK IN THE MIDDLE. THE HANDLE COULD NOT BE FULLY SQUEEZED. THE SURGEON HAD TO RESECT MORE TISSUE THAN WHAT WAS ORIGINALLY PLANNED DUE TO THE PRODUCT PROBLEM. ANOTHER DEVICE WAS USED. NO BLEEDING WAS REPORTED. NOTHING FELL INTO THE PATIENT CAVITY. OPERATIVE TIME WAS EXTENDED MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA UNIVERSAL | DISPOSABLE STAPLER | GDW | USSC PUERTO RICO | N1A0491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | LOT #: P1A0856| EXP: 01/31/2016| K061095| ENDO GIA II 60-3.5 SULU, CATALOG #: 030414| MANF: 01/01/2011 |