FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE LAPAROSCOPIC SHEAR 23CM LENGTH
MDR report key: 3010431
·
Received March 19, 2013
Report
- Report Number
- 3005075853-2013-01276
- Event Type
- Malfunction
- Date Received
- March 19, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 6, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K120729
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Description of Event or Problem · 1
AFTER A REVIEW OF THE FILE, AN INPUT ERROR OCCURRED AND THIS FILE IS NOT REPORTABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE FIRST DEVICE WAS WORKING FINE THE THERE WAS AN ERROR MESSAGE TO RELAX PRESSURE THEN AN ERROR APPEARED TO TIGHTEN HAND PIECE. THE STAFF SHUT DOWN THE GENERATOR AND TIGHTENED THE DEVICE THEN TRIED AGAIN AND REPLACE ERROR MESSAGE APPEARED. THE SECOND DEVICE WORKED FOR THREE BITES THEN THE DEVICE BEEPED BUT THERE WAS NO ENERGY AT ALL. ANOTHER ENERGY DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114635 | HARMONIC ACE LAPAROSCOPIC SHEAR 23CM LENGTH | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | J93104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR, HANDPIECE |