FDA Adverse Event
Malfunction
Summary report: N
FOOTSWITCH PULSAR WIRELESS
MDR report key: 4706646
·
Received April 20, 2015
Report
- Report Number
- 1226420-2015-00065
- Event Type
- Malfunction
- Date Received
- April 20, 2015
- Date of Event
- March 20, 2015
- Report Date
- March 20, 2015
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- GEI
- PMA / PMN Number
- K073057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT # (B)(4). EVAL, METHOD, RESULTS, CONCLUSION: FACILITY NOT RETURNING PRODUCT. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
DURING ANNUAL PM CHECK THE CUSTOMER FOUND THAT THE OUTPUT WAS HIGH ON COAG 5. CUSTOMER WAS GETTING BETWEEN 47.5 AND 49.5 WATTS OF OUTPUT ON COAG 5. CUSTOMER WAS USING A DNI 402A ESU ANALYZER WITH A TNA HAND PIECE AND FOOTSWITCH TO TEST. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261066 | FOOTSWITCH PULSAR WIRELESS | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MEDTRONIC ADVANCED ENERGY, LLC | PS100-200 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |