FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 1875069
·
Received October 14, 2010
Report
- Report Number
- 1056128-2010-00076
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Date of Event
- September 16, 2010
- Report Date
- October 14, 2010
- Manufacturer
- ASCENT
- Product Code
- NLQ
- PMA / PMN Number
- K043315
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT THE DEVICE HAS NOT BEEN RETURNED TO ASCENT FOR EVAL AND AN INVESTIGATION HAS NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED A F/U MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MINIMUM BUTTON ON THE ULTRASONIC SCALPEL WAS NOT WORKING. THE PT WAS REPORTED TO BE IN SATISFACTORY CONDITION AFTER THE PROCEDURE AND NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | NLQ | ASCENT | ACE36E | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |