FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 2133644
·
Received June 8, 2011
Report
- Report Number
- 1219930-2011-00491
- Event Type
- Injury
- Date Received
- June 8, 2011
- Date of Event
- May 26, 2011
- Report Date
- June 2, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: AFTER 2ND FIRING, IT WAS NOTICED THE FIRST STAPLING LINE WAS PARTLY TORN. ANOTHER DEVICE WAS USED, AND ADDITIONAL SUTURING WAS APPLIED TO THE SUTURE STAPLE LINE. NO BLEEDING WAS REPORTED. NOTHING FELL INTO THE PT CAVITY. MORE THAN 3CM OF TISSUE HAD TO BE RESECTED. OPERATING TIME WAS EXTENDED MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N0M0093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | ENDO GIA ROTICULATOR 60-3.5 SULU: CATALOG# 030458,| LOT# N0H0721, EXPIRATION: 08/31/2015 |