FDA Adverse Event
Malfunction
Summary report: N
HARMONIC FOCUS* CURVED SHEAR 17CM
MDR report key: 3971542
·
Received July 31, 2014
Report
- Report Number
- 3005075853-2014-05381
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- July 25, 2014
- Report Date
- July 28, 2014
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K063192
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION NOT AVAILABLE, 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 PANCREATODUODENECTOMY, THE DEVICE WAS ACTIVATED WITHOUT PRESSING THE HAND SWITCH. AN (B)(4) 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 |
|---|---|---|---|---|---|---|---|
| 448284 | HARMONIC FOCUS* CURVED SHEAR 17CM | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |