FDA Adverse Event
Malfunction
Summary report: N
ELECTROSURGERY PROBE PLUS II
MDR report key: 1112659
·
Received August 11, 2008
Report
- Report Number
- 3005075853-2008-01084
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 25, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K912492
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE WATER LEAKED FROM THE TUBE, AND THE TIP WAS JAMMED. OTHER DEVICES WERE USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTROSURGERY PROBE PLUS II | GCJ | ETHICON ENDO-SURGERY, LLC | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |