FDA Adverse Event
Malfunction
Summary report: N
WECK HEM-O-LOK ENDO APPLIER
MDR report key: 2121741
·
Received May 20, 2011
Report
- Report Number
- 1044475-2011-00060
- Event Type
- Malfunction
- Date Received
- May 20, 2011
- Report Date
- May 6, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FZP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: "THE WORK ELEMENT BROKE DURING THE SURGERY, NO PARTS WERE DROPPED OR MISSING. NO CONSEQUENCE." DEFECT WAS DISCOVERED DURING USE ON A PATIENT. THE DEVICE THAT WAS USED WAS RE-STERILIZED/REPROCESSED PRIOR TO THE ALLEGED EVENT. TYPE OF PROCEDURE PERFORMED IS UNKNOWN. NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK HEM-O-LOK ENDO APPLIER | ENDO APPLIER | FZP | TELEFLEX MEDICAL | NA | 0746900-044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |