FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR SEALER AQM MBS W/LIGHT
MDR report key: 5646370
·
Received May 11, 2016
Report
- Report Number
- 1226420-2016-00047
- Event Type
- Malfunction
- Date Received
- May 11, 2016
- Date of Event
- April 11, 2016
- Report Date
- April 12, 2016
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- GEI
- PMA / PMN Number
- K073495
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT: (B)(4). PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
DURING A TKA PROCEDURE THE SURGEON NOTED THAT THE DEVICE ACTIVATION BUTTON WOULD STICK SUCH THAT RF ENERGY DELIVERY CONTINUED UPON RELEASE OF THE ACTIVATION BUTTON. A SECOND DEVICE WAS UTILIZED AND THE REPORTED ISSUE WAS REPEATED. NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301363 | BIPOLAR SEALER AQM MBS W/LIGHT | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MEDTRONIC ADVANCED ENERGY, LLC | 23-301-1 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |