FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH** XCEL*
MDR report key: 1934040
·
Received December 21, 2010
Report
- Report Number
- 3005075853-2010-07311
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 30, 2010
- Report Date
- December 1, 2010
- 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
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND EVIDENCE THAT THE DEVICE HAS BEEN REPROCESSED BY ASCENT HEALTH CARE SOLUTIONS; THEREFORE, NO TESTING WAS PERFORMED TO EVALUATE THE INCIDENT REPORTED. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS. THE TROCAR WAS LEAKING PNEUMO. THE SAME DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH** XCEL* | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |