FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC ACE
MDR report key: 2945516
·
Received February 6, 2013
Report
- Report Number
- 3005075853-2013-00507
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- January 25, 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). DEVICE NOT RETURNED FOR ANALYSIS. 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 LOW ANTERIOR RESECTION, THE TISSUE PAD DETACHED OFF WHEN THE TISSUE PAD WAS WIPED WITH WET GAUZE OUTSIDE THE PATIENT'S ABDOMEN IN ABOUT 1 HOUR. THE TISSUE PAD DID NOT FALL INTO 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 |
|---|---|---|---|---|---|---|---|
| 50473 | ULTRACISION HARMONIC ACE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |