FDA Adverse Event
Malfunction
Summary report: N
WECK ENDO FASCIAL CLOSURE SYSTEM
MDR report key: 3886524
·
Received April 14, 2014
Report
- Report Number
- 1044475-2014-00110
- Event Type
- Malfunction
- Date Received
- April 14, 2014
- Date of Event
- March 26, 2014
- Report Date
- March 27, 2014
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE SAMPLE RECEIVED BY MANUFACTURER, BUT INVESTIGATION IS STILL UNDERWAY AT TIME OF THIS REPORT.
Description of Event or Problem · 1
COMPLAINT ALLEGES: THE TIP OF THE EFX BROKE OFF DURING USE IN A LAP CHOLE SURGERY. THE DOCTOR REPORTED THAT THE SUTURE PASSER MISSED THE SILICONE PADS AND PUSHED OUTSIDE THE WINGS. WHEN THE SURGEON PULLED THE SUTURE PASSER OUT, HE NOTICED THAT THE TIP WAS MISSING. UNDER A SCOPE, HE SAW THE TIP LYING ON THE PATIENT'S BOWEL AND HE REMOVED IT WITH A GRASPER. THERE WAS NO INJURY TO THE PATIENT DUE TO THIS INCIDENT. PATIENT CURRENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228239 | WECK ENDO FASCIAL CLOSURE SYSTEM | FASCIAL CLOSURE SYSTEM | GCJ | TELEFLEX MEDICAL | EF038224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |