FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT
MDR report key: 1810016
·
Received November 12, 2007
Report
- Report Number
- 1527736-2007-07506
- Event Type
- Malfunction
- Date Received
- November 12, 2007
- Date of Event
- October 18, 2007
- Report Date
- October 23, 2007
- 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
- HK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR, AN ERROR CODE 5 WAS ALARMED AND THE BLADE TIP BROKE. THE BROKEN PIECE FELL INTO THE PT, BUT AFTER 15 MINS, THE SURGEON FOUND IT AND TOOK IT OUT. THERE WAS NO PT CONSEQUENCE.
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 | GEI | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | D4GK12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |