FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL HAND PIECE
MDR report key: 1182768
·
Received October 3, 2008
Report
- Report Number
- 1527736-2008-03710
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Date of Event
- May 23, 2008
- Report Date
- May 26, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- LFL
- PMA / PMN Number
- K002906
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 06/13/2008. EVAL SUMMARY: THE HAND PIECE WAS RETURNED WITH A NOSE CONE CRACKED AND LOOSE MOUNT. IT WAS TESTED ON A GENERATOR AND NO ERROR CODES WERE NOTED. THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTE DURING THE MFG PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE DID NOT WORK. NO REPORTED PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL HAND PIECE | NONE | LFL | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR |