FDA Adverse Event
Injury
Summary report: N
JARIT
MDR report key: 290927
·
Received August 14, 2000
Report
- Report Number
- 2430952-2000-00003
- Event Type
- Injury
- Date Received
- August 14, 2000
- Date of Event
- August 3, 2000
- Report Date
- August 14, 2000
- Manufacturer
- KOSCHER & WUERTZ GMBH, CHIRURGISCHE INSTRUMENTE
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING THE PERFORMANCE OF A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TIP OF A 5MM DOUBLE CUP GRASPER BROKE OFF, FALLING INTO THE OPERATIVE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JARIT | 5MM DOUBLE CUP GRASPER | GCJ | KOSCHER & WUERTZ GMBH, CHIRURGISCHE INSTRUMENTE | 625-108 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Required Intervention |