FDA Adverse Event
Malfunction
Summary report: N
JARIT-VANGUARD CRILE FORCEPS, CURVED, 6 14"
MDR report key: 1064442
·
Received June 9, 2008
Report
- Report Number
- 2430952-2008-00016
- Event Type
- Malfunction
- Date Received
- June 9, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR.
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 14" | JARIT GENERAL OPERATING INSTRUMENTS | HTD | ELMED INSTRUMENTS (PVT.) LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |