FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH** XCEL* TROCAR
MDR report key: 2173030
·
Received July 23, 2011
Report
- Report Number
- 3005075853-2011-02947
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- July 13, 2011
- Report Date
- July 14, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GCJ
- PMA / PMN Number
- K032676
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE TROCAR LEAKED FROM THE SEAL. THERE WAS TORQUE WITH THE INSTRUMENT. A NEW TROCAR WAS USED TO COMPLETE. THERE WAS NO PATIENT IMPACT. BOTH TROCARS WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH** XCEL* TROCAR | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | H43R0M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |