FDA Adverse Event
Summary report: N
ULTRACISION HARMONIC ACE
MDR report key: 3884406
·
Received June 19, 2014
Report
- Report Number
- 3005075853-2014-04143
- Date Received
- June 19, 2014
- Date of Event
- June 5, 2014
- Report Date
- June 12, 2014
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CLARIFICATION RECEIVED THAT THE TISSUE PAD DID NOT FALL OFF THE CLAMP ARM.
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. 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
IT WAS REPORTED THAT DURING A LAP GASTRIC PROCEDURE, ¿RELAX PRESSURE ON BLADE¿ WAS DISPLAYED FREQUENTLY AND THEN, THE TISSUE PAD LIFTED OFF THE CLAMP ARM. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361921 | ULTRACISION HARMONIC ACE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | NA | L90969 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |