FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 45-3.5 SULU
MDR report key: 2032576
·
Received March 22, 2011
Report
- Report Number
- 1219930-2011-00225
- Event Type
- Injury
- Date Received
- March 22, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- UNITEDS STATES SURGICAL A
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: IN THE LAPAROSCOPIC SURGERY IN LOW RECTAL, THE DOCTOR USED THE ENDO GIA TO CUT THE RECTUM. THE CUTTING PROCESS WAS SMOOTH. THE SURGEON REALIZED THAT THE STAPLE LINE WAS COMING LOOSE AND DID NOT FORM PROPERLY. SURGERY TIME WAS EXTENDED BY ONE HOUR. THE PT CURRENT CONDITION WAS REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 45-3.5 SULU | DISPOSABLE STAPLER | GDW | UNITEDS STATES SURGICAL A | N0C0734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other | LOT NUMBER: N0H0178, EXPIRATION DATE: 08/31/2015| ENDO GIA UNIVERSAL 12MM SINGLE USE, (B)(4)| MANUFACTURE DATE: 08/2010 |