FDA Adverse Event
Malfunction
Summary report: N
MAE UNKNOWN PEAK PLASMABLADE
MDR report key: 5001572
·
Received August 13, 2015
Report
- Report Number
- 1226420-2015-00135
- Event Type
- Malfunction
- Date Received
- August 13, 2015
- Date of Event
- July 17, 2015
- Report Date
- July 17, 2015
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(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 INVESTIGATION AT AN MAE SERVICE CENTER, IT WAS IDENTIFIED THAT THE GENERATOR HAD DISCONNECTED INTERNAL WIRES LIKELY DUE TO USER TAMPERING. UPON RE-CONNECTION OF THESE WIRES, AN INTERNAL COMPONENT SPARKED CAUSING AN INCREASE IN CURRENT FLOW, RESULTING IN A FAILURE OF INTERNAL GENERATOR COMPONENTS. NO PATIENT INVOLVED THEREFORE NO PATIENT INFORMATION OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 536581 | MAE UNKNOWN PEAK PLASMABLADE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MEDTRONIC ADVANCED ENERGY, LLC | MAE UNK PEAK DEV | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |