FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLUNT TIP TROCAR
MDR report key: 2013713
·
Received March 10, 2011
Report
- Report Number
- 3005075853-2011-00978
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- February 12, 2011
- Report Date
- February 15, 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE CAUSED INSUFFLATION ISSUES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL BLUNT TIP TROCAR | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | UNK | H43057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |