FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 23 CM
MDR report key: 1081066
·
Received July 21, 2008
Report
- Report Number
- 3005075853-2008-00585
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- May 26, 2008
- Report Date
- June 25, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 AN UNKNOWN PROCEDURE, THE BLADE BROKE. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 23 CM | LFL | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |