FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL HAND PIECE
MDR report key: 1820181
·
Received October 30, 2007
Report
- Report Number
- 1527736-2007-07171
- Event Type
- Malfunction
- Date Received
- October 30, 2007
- Date of Event
- March 28, 2007
- Report Date
- April 26, 2007
- 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT. IT WAS TESTED ON A GENERATOR GAVE AN ERROR CODE 5. ALSO, A HISSING SOUND WAS NOTED. THE HAND PIECE WAS DISASSEMBLED; A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE DID NOT WORK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL HAND PIECE | LFL | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR |