FDA Adverse Event
Malfunction
Summary report: N
WECK ENDO FASCIAL CLOSURE SYSTEM
MDR report key: 3837863
·
Received March 6, 2014
Report
- Report Number
- 1044475-2014-00050
- Event Type
- Malfunction
- Date Received
- March 6, 2014
- Date of Event
- February 5, 2014
- Report Date
- February 11, 2014
- Manufacturer
- TELEFLEX
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
COMPLAINT ALLEGED: AFTER A ROBOTIC TOTAL HYSTERECTOMY, THE SURGEON USED AN EFX DEVICE TO CLOSE THE CAMERA PORT. THE SUTURE PASSER WAS ADVANCED THROUGH THE SILICONE PAD AND POPPED THROUGH, HITTING THE OMENTUM. BLEEDING WAS NOTICED ON THE OMENTUM, THE BOWEL WAS CHECKED BUT NO LESIONS OR LACERATIONS WERE NOTED. THE PT WAS ADMITTED TO THE HOSPITAL AND WAS "OBSERVED TO HAVE A SMALL BOWEL LACERATION." AN EXPLORATORY LAPAROTOMY AND SMALL BOWEL RESECTION WAS PERFORMED. PT CURRENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134399 | WECK ENDO FASCIAL CLOSURE SYSTEM | FASCIAL CLOSURE EYSTEM | GCJ | TELEFLEX | EF038654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |