FDA Adverse Event
Malfunction
Summary report: N
RF ASSURE MODEL 200LD-V
MDR report key: 7007986
·
Received November 7, 2017
Report
- Report Number
- 1717344-2017-06182
- Event Type
- Malfunction
- Date Received
- November 7, 2017
- Date of Event
- October 13, 2017
- Report Date
- November 7, 2017
- Manufacturer
- MITG - RF SURGICAL SYSTEMS
- Product Code
- LWH
- UDI-DI
- 10884521700659
- PMA / PMN Number
- K062642
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT SAMPLE WAS REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE OR ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER THE UNIT GAVE A FALSE POSITIVE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 784833 | RF ASSURE MODEL 200LD-V | COUNTER, SPONGE, SURGICAL | LWH | MITG - RF SURGICAL SYSTEMS | 01-0034 | 10884521700659 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |