FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC ACE
MDR report key: 2945555
·
Received February 6, 2013
Report
- Report Number
- 3005075853-2013-00508
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- January 29, 2013
- Report Date
- January 29, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY, THE BLADE WAS BROKEN OFF AFTER IT WAS CLEANED WITH NORMAL SALINE IN THE MIDDLE OF THE OPERATION. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50768 | ULTRACISION HARMONIC ACE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | J90Y91 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |