FDA Adverse Event
Malfunction
Summary report: N
PRESTIEGE ATRAUMATIC GRASPER
MDR report key: 157851
·
Received March 19, 1998
Report
- Report Number
- 1921846-1998-00006
- Event Type
- Malfunction
- Date Received
- March 19, 1998
- Report Date
- February 17, 1998
- Manufacturer
- ACUFEX MICROSURGICAL, INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS, THAT THE GRASPER TIP FELL APART AS THE NURSE HANDED IT TO THE SURGEON, BEFORE STARTING A PROCEDURE. THE TIP DID NOT COME IN CONTACT WITH A PT. THERE WAS NO PT INJURY. THE NURSE ACKNOWLEDGED SHE SHOULD HAVE SENT THE GRASPER IN EARLIER FOR REPAIR WHEN IT WAS FOUND THE TEETH WERE LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESTIEGE ATRAUMATIC GRASPER | LAPAROSCOPIC SURGICAL INSTRUMENT | GCJ | ACUFEX MICROSURGICAL, INC. | NA | 888054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |