FDA Adverse Event
Malfunction
Summary report: N
PRESTIGE ATRAUMATIC GRASPER
MDR report key: 155604
·
Received March 11, 1998
Report
- Report Number
- 1946801-1998-00004
- Event Type
- Malfunction
- Date Received
- March 11, 1998
- Report Date
- February 9, 1998
- Manufacturer
- ACUFEX MICROSURGICAL, INC
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS, THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE ATRAUMATIC GRASPER DEVICE BROKE AT THE JAW. THE BROKEN PART DID NOT FALL INTO THE PATIENT AND IT WAS RECOVERED UNEVENFULLY. THERE WAS NO INJURY AND/OR SIGNIFICANT DELAY DURING THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESTIGE ATRAUMATIC GRASPER | LAPROSCOPIC SURGERY INSTRUMENT | GCJ | ACUFEX MICROSURGICAL, INC | N/A | 884052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |