FDA Adverse Event
Injury
Summary report: N
ENDO UNIVERSAL 65 12 MM INSTR. W/4.0MM DLU
MDR report key: 1140283
·
Received August 29, 2008
Report
- Report Number
- 2647580-2008-00506
- Event Type
- Injury
- Date Received
- August 29, 2008
- Date of Event
- July 17, 2008
- Report Date
- August 11, 2008
- Manufacturer
- PONCE - USS
- Product Code
- GDW
- PMA / PMN Number
- K912097
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE HERNIA REPAIR HAD BEEN COMPLETED 4 OR 5 YEARS BEFORE BUT THE PT HAD BEEN COMPLAINING OF PAIN AT THE SITE, AND IT WAS DETERMINED BY THE TREATING PHYSICIAN THAT A STAPLE WAS POSSIBLY PINCHING A NERVE. THE PT UNDERWENT DAY SURGERY IN 2008, HAD THE STAPLE REMOVED AND IN THE PROCESS SOME TISSUE WAS CUT OUT SINCE THE STAPLE WAS EMBEDDED IN TISSUE. THE NURSE WAS ASKED ABOUT BLEEDING, BUT NO INFO WAS OFFERED. THE SAMPLE WILL NOT BE RETURNED. NO OTHER INFO WAS GIVEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO UNIVERSAL 65 12 MM INSTR. W/4.0MM DLU | SURGICAL STAPLER | GDW | PONCE - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |