FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL LAPAROSCONIC COAGULATING SHEARS (LCS), SCISSORGRIP
MDR report key: 1112643
·
Received August 11, 2008
Report
- Report Number
- 3005075853-2008-01073
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 17, 2008
- Report Date
- July 28, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GEI
- PMA / PMN Number
- K002981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID COLECTOMY PROCEDURE, THE METAL TIP BROKE OFF. THE FRAGMENT WAS REMOVED WITHOUT INCIDENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL LAPAROSCONIC COAGULATING SHEARS (LCS), SCISSORGRIP | GEI | ETHICON ENDO-SURGERY, LLC | NA | D4HC5L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |