FDA Adverse Event
Malfunction
Summary report: N
BLADELESS TROCAR
MDR report key: 2935728
·
Received January 30, 2013
Report
- Report Number
- 3005075853-2013-00395
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- January 4, 2013
- Report Date
- March 26, 2024
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ABDOMINAL RECTOSIGMOIDECTOMY/ENTERORRHAPHY PROCEDURE, THE TROCAR MEMBRANE BROKE WHEN THE PERMANENT CLIPPER PASSED THROUGH IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40929 | BLADELESS TROCAR | Laparoscope, general & plastic surgery | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | J4AX2A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | CLIPPER.| CLIPPER |