FDA Adverse Event
Injury
Summary report: N
ENDO CLIP 5MM CLIP APPLIER
MDR report key: 1222110
·
Received November 5, 2008
Report
- Report Number
- 1219930-2008-00808
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- October 3, 2008
- Report Date
- October 3, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDO
- PMA / PMN Number
- K954435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 11/05/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: LAP CHOLE - PEDIATRIC. PATIENT GENDER: UNKNOWN. ACCORDING TO THE REPORTER THAT THE CLIP WOULD SPIT OUT UNFORMED AND THEN THE INSTRUMENT WOULD LOCK UP AND THE RED LINE WOULD EXPOSE IN THE BACK INDICATING THERE WERE NO MORE CLIPS. SOME INSTRUMENTS WOULD SPIT ONE OR TWO CLIPS THEN LOCK OUT. NO SIGNIFICANT BLOOD LOSS AND SURGERY TIME WAS EXTENDED AROUND 30 MINUTES AS A RESULT. PATIENT IS IN WELL CURRENT CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CLIP 5MM CLIP APPLIER | DISPOSABLE SURGICAL CLIP APPLIER | GDO | NORTH HAVEN - USS | N8F58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R | LOT# N8G446 EXP DATE 07/31/2013| LOT# N8F58 EXP DATE 06/30/2013| LOT# N8G328 EXP DATE 07/31/2013| LOT# N7M148 EXP DATE 12/31/2012 |