FDA Adverse Event
Injury
Summary report: N
GIA 60-3.8 SINGLE USE RELOADABLE STAPLER
MDR report key: 1024774
·
Received April 2, 2008
Report
- Report Number
- 2647580-2008-00190
- Event Type
- Injury
- Date Received
- April 2, 2008
- Date of Event
- February 26, 2008
- Report Date
- March 5, 2008
- Manufacturer
- PONCE - USS
- Product Code
- GAG
- PMA / PMN Number
- K013860
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 04/02/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: INTESTINAL VALVE REPAIR. ACCORDING TO THE REPORTER: PHYSICIAN THOUGHT THAT HE WAS USING A BLADELESS INSTRUMENT, HOWEVER, THE WRONG BOX WAS OPENED AND A BLADED STAPLER WAS INADVERTENTLY USED. SURGEON INADVERTENTLY STAPLED AND DIVIDED THE INTESTINAL VALVE. THE VALVE WAS REPAIRED BY SUTURING. THE PT HAS RECOVERED AND HAS BEEN DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA 60-3.8 SINGLE USE RELOADABLE STAPLER | DISPOSABLE SURGICAL STAPLER | GAG | PONCE - USS | P7L0547 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |