FDA Adverse Event
Malfunction
Summary report: N
JARIT-VANGUARD CRILE FORCEPS, CURVED, 6 1/4"
MDR report key: 1173803
·
Received June 27, 2008
Report
- Report Number
- 2430952-2008-00016_2
- Event Type
- Malfunction
- Date Received
- June 27, 2008
- Date of Event
- May 9, 2008
- Report Date
- June 9, 2008
- Manufacturer
- ELMED INSTRUMENTS (PVT). LTD.
- Product Code
- HTD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE USER FACILITY REPORTS THAT DURING A KIDNEY TRANSPLANT, THE CRILE FORCEP'S BOX LOCK FRACTURED/BROKE, WHILE BEING USED BY THE SURGEON. THE INSTRUMENT WAS IN CONTACT WITH THE PT, BUT THERE WAS NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JARIT-VANGUARD CRILE FORCEPS, CURVED, 6 1/4" | JARIT GENERAL OPERATING INSTRUMENTS | HTD | ELMED INSTRUMENTS (PVT). LTD. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |