FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT
MDR report key: 1190926
·
Received October 9, 2008
Report
- Report Number
- 1527736-2008-03526
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- March 8, 2008
- Report Date
- May 20, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GEI
- PMA / PMN Number
- K002981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- 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 LAP LIVER RESECTION PROCEDURE, THE TIP OF THE DEVICE BROKE OFF INTO THE PT. THE TIP WAS REMOVED THROUGH THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT | NONE | GEI | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | D4JF7L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |