FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL LAPAROSONIC BALL COAGULATOR - 5 MM DIAMETER
MDR report key: 1210055
·
Received October 22, 2008
Report
- Report Number
- 3005075853-2008-02506
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 1, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GEI
- PMA / PMN Number
- K990362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- 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 THE DEVICE WAS USED DURING AN OPERATIVE LAPAROSCOPY. THE TIP (BALL) BROKE OFF OF THE DEVICE, THIS OCCURRED OUTSIDE OF THE PT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL LAPAROSONIC BALL COAGULATOR - 5 MM DIAMETER | GEI | ETHICON ENDO-SURGERY, LLC | NA | D4HG33 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |