FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 2221533
·
Received August 17, 2011
Report
- Report Number
- 1219930-2011-00693
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- August 11, 2011
- Report Date
- August 11, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: PNEUMOTHORAX BULLA RESECTION. ACCORDING TO THE REPORTER: AFTER THE 1ST FIRING, THE RETURN KNOB WAS RETURNED, BUT THE KNIFE AND CLAMP COVER WOULD NOT RETURN. ADD'L RESECTION OF TISSUE WAS NEEDED. THE RELEASING BLUE BUTTON WAS PRESSED AND THE CARTRIDGE WAS REMOVED FROM THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL | N1C0312X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | EXP: 11/30/2014, MANUF: 11/2009, (B)(4)| DUET TRS 60 3.5MM ARTICULATING SULU| CATALOG# DUET6035A, LOT# N9L0109U |