FDA Adverse Event
Malfunction
Summary report: N
WECK HEM-O-LOK ENDO APPLIER, ML
MDR report key: 2062440
·
Received March 18, 2011
Report
- Report Number
- 1044475-2011-00023
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Report Date
- February 23, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FZP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS NOT AVAILABLE FOR EVALUATION BY MANUFACTURER. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE SURGEON USED THE APPLIER DURING A PROCEDURE AND IT DID NOT ALLOW CLIP TO CLOSE AND LOCK PROPERLY. SURGEON REPORTED THAT THE APPLIERS FAILED TO ENGAGE THE CLIP CORRECTLY AND WOULD NOT LOCK ONTO THE STRUCTURE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK HEM-O-LOK ENDO APPLIER, ML | HEM-O-LOK ENDO APPLIER | FZP | TELEFLEX MEDICAL | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |