HARMONIC SCALPEL** GENERATOR
Report
- Report Number
- 3005075853-2010-05915
- Event Type
- Injury
- Date Received
- October 18, 2010
- Date of Event
- October 5, 2010
- Report Date
- October 12, 2010
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K002906
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
(B)(6) .
(B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. CUSTOMER NOT RETURNING AS DETERMINE IT WAS A USER ERROR AND NOT AN ERROR WITH THE GENERATOR.
IT WAS REPORTED THAT DURING A LAVH, THE SYSTEM RESPONDED WITH AN UNKNOWN ERROR. THE ERROR KEPT RE-OCCURRING WHILE THE DOCTOR WAS TRYING TO SEAL A VESSEL. THE CASE WAS CONVERTED TO OPEN. BLOOD LOSS WAS NOTED AT 1500CC. PATIENT WAS FEMALE BUT OTHER DEMOGRAPHICS WERE UNKNOWN. POST PROCEDURE CARE WAS UNKNOWN. THE STAFF BELIEVES THE GENERATOR IS THE ISSUE. THE DEVICE WILL NOT BE RETURNED AT THIS TIME. THE CASE WAS DELAYED APPROXIMATELY ONE HOUR. ADDITIONAL INFORMATION RECEIVED: THE GENERATOR WAS GIVING ERROR CODES - HOWEVER IT WAS DUE TO NOT RUNNING THE TEST MODE TO COMPLETION. INSTRUCTIONS FOR USE STATE: TURN THE GENERATOR POWER SWITCH ON AND OBSERVE THE POWER-UP SEQUENCE. THE SYSTEM WILL RUN ITS START-UP SEQUENCE AND DISPLAY THE SOFTWARE VERSION. AN AUDIBLE TONE WILL SOUND DURING THE INITIATION SEQUENCE. WHEN THE INITIATION SEQUENCE IS COMPLETE, THE SYSTEM WILL GO TO STANDBY. AFTER COMPLETING SYSTEM SETUP, THE SYSTEM MAY BE OPERATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL** GENERATOR | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |