FDA Adverse Event
Malfunction
Summary report: N
ELECTROSURGERY PROBE PLUS II
MDR report key: 2133561
·
Received June 20, 2011
Report
- Report Number
- 3005075853-2011-02483
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- May 20, 2011
- Report Date
- May 26, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GCJ
- PMA / PMN Number
- K912492
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDED ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS TESTED FOR CONTINUITY AND WAS FOUND TO BE CONFORMING. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE.
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE COULD NOT BE ACTIVATED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTROSURGERY PROBE PLUS II | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | UNK | H43186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDLE |