FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR SEALER W/CUT AQM3 8.2L
MDR report key: 3160481
·
Received June 10, 2013
Report
- Report Number
- 1226420-2013-00115
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- May 6, 2013
- Report Date
- June 10, 2013
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- DWG
- PMA / PMN Number
- K111285
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVAL CODE METHOD: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. EVAL CODE RESULTS: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. PRODUCT EVENT: (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
DOCTOR¿S HAND WAS SORE THE DAY AFTER SURGERY DUE TO HOT SALINE RUN OFF. NO VISUAL BURNS, BUT DOCTOR DID EXPERIENCE DISCOMFORT. NO MEDICAL INTERVENTION ADMINISTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259722 | BIPOLAR SEALER W/CUT AQM3 8.2L | ELECTROSURGICAL DEVICE | DWG | MEDTRONIC ADVANCED ENERGY, LLC | 25-102-1 | 21205402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |