FDA Adverse Event
Injury
Summary report: N
GIA 90 PREMIUM STAINLESS STEEL DLU
MDR report key: 1743884
·
Received June 28, 2007
Report
- Report Number
- 2647580-2010-00594
- Event Type
- Injury
- Date Received
- June 28, 2007
- Date of Event
- May 12, 2010
- Report Date
- June 7, 2010
- Manufacturer
- USSC PUERTO RICO
- Product Code
- FHM
- PMA / PMN Number
- K801590
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: INSTRUMENT WAS FIRED. TISSUE WAS TRANSECTED, BUT NO STAPLES WERE FIRED. IT WAS OBSERVED THAT THERE WERE NO STAPLES IN THE CARTRIDGE. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. NO TISSUE DAMAGE OR PT INJURY REPORTED. NO ADD'L BLEEDING AND THE OPERATING TIME WAS NOT EXTENDED OVER 30 MINUTES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA 90 PREMIUM STAINLESS STEEL DLU | SURGICAL STAPLES | FHM | USSC PUERTO RICO | P9E0181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| S |