FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1191185
·
Received October 9, 2008
Report
- Report Number
- 1527736-2008-03623
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- May 21, 2008
- Report Date
- May 23, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE NURSE NOTICED THAT THE BLADE WAS BROKEN WHEN IT WAS WIPED AFTER THE OPERATION. IT WAS BROKEN OUT OF THE BODY AND THE BROKEN PIECE WAS ALREADY REMOVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | NONE | LFL | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | D4JN6R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |