FDA Adverse Event
Other
Summary report: N
INSULATED HANDLE
MDR report key: 1303792
·
Received January 30, 2009
Report
- Report Number
- 9611612-2009-00006
- Event Type
- Other
- Date Received
- January 30, 2009
- Report Date
- January 30, 2009
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- GCJ
- PMA / PMN Number
- K011997
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURES LIKE THE REPORTED ONE ARE NOTICED BY USER PRIOR TO USE BECAUSE THE DEVICE HAS TO BE ASSEMBLED AND INSPECTED. NO PATIENT/USER/THIRD PERSON WAS HARMED, NOT EVEN ENDANGERED. NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE AFFECTED DEVICE HISTORY RECORD AND THE RAW MATERIAL HISTORY FILES FOR THE REPORTED BATCH SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. IF NO FURTHER INFORMATION IS AVAILABLE ALLOWING PAJUNK TO DETERMINE THE ROOT CAUSE THE FILE IS CONSIDERED AS CLOSED.
Description of Event or Problem · 1
WHEN INSTRUMENT WAS CHECKED AND ASSEMBLED PRIOR TO USE IT WAS NOTICED IT DID NOT WORK PROPERLY ANYMORE. NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSULATED HANDLE | LAPAROSCOPE GENERAL AND PLASTIC SURGERY | GCJ | PAJUNK GMBH MEDIZINTECHNOLOGIE | 1298-61-00 | BK= 02/2008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |