FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL GENERATOR
MDR report key: 1823846
·
Received December 12, 2007
Report
- Report Number
- 1527736-2007-08472
- Event Type
- Malfunction
- Date Received
- December 12, 2007
- Report Date
- December 3, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND TO CORRECT THE COMPLAINT THE MAIN PC BOARD WAS REPLACED. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED VIA THE DATABASE. THE UNIT HAS PASSED ALL QA INSPECTIONS. AFTER SERVICING THE UNIT PASSED ALL QA FUNCTIONAL TESTING. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ERROR CODE 1 OCCURRED WITH THE GENERATOR WITH AN UNKNOWN PROCEDURE. IT WAS NOT NOTED IF THE ERROR OCCURRED DURING A PROCEDURE. NO PATIENT CONSEQUENCE REPORTED. UNIT WILL NOT BE RETURNED TO THE INTERNATIONAL SERVICE CENTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL GENERATOR | LFL | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE |