FDA Adverse Event
Malfunction
Summary report: N
HEMOLOK TAKE-A-APART 5MM ENDO APPLIER
MDR report key: 1981306
·
Received February 2, 2011
Report
- Report Number
- 1044475-2011-00013
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 12, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FZP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U INVESTIGATION REPORT WILL BE SUBMITTED WHEN COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: DURING A PROSTATECTOMY SURGERY THE LITTLE SCREW IN THE JAW OF THE APPLIER WAS LOST. INTENSIVE WASHING OF THE ABDOMINAL CAVITY WAS PERFORMED WITHOUT LOCATION OF THE SCREW. ALL FLUIDS COLLECTED DURING THE SURGERY WERE ALSO FILTERED AND THE SCREW WAS NOT LOCATED. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOLOK TAKE-A-APART 5MM ENDO APPLIER | TAKE-A-APART APPLIER | FZP | TELEFLEX MEDICAL | NA | 080041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |