FDA Adverse Event
Summary report: N
KARL STORZ
MDR report key: 3113319
·
Received May 26, 2006
Report
- Report Number
- 9610617-2006-00032
- Date Received
- May 26, 2006
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- GCJ
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
JAW BROKE OFF WHERE IT WAS CONNECTED TO HINGE. RISK MANAGER FROM HOSPITAL STATED THAT HE BELIEVES THAT INSTRUMENT BROKE DUE TO TOO MUCH WEIGHT BEING GRASPED CAUSING MECHANICAL OVERLOAD OF INSTRUMENT. CONDITION OF INSTRUMENT IS CONSISTENT WITH DAMAGE CAUSED BY MECHANICAL OVERLOAD.
Description of Event or Problem · 1
PLEASE REFER IMPORTER REPORT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | BOWEL GRASPER | GCJ | KARL STORZ GMBH & CO. KG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |