MULClass II
Generator, Electrosurgical, Coagulation, Cancer
General, Plastic Surgery · 21 CFR 878.4400
MDR events149All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
149 adverse event reports on file
- ARTHROCARE COBLATOR IIOct 7, 2015MalfunctionSmith & Nephew Inc5131045
- GENERATOR PULSAR IIDec 22, 2014MalfunctionMedtronic Advanced Energy, Llc1226420-2014-00128
- GENERATOR PULSAR REFURBISHEDDec 15, 2014MalfunctionMedtronic Advanced Energy, Llc1226420-2014-00123
- GENERATOR PS100-102 PULSAR IIDec 15, 2014MalfunctionMedtronic Advanced Energy, Llc1226420-2014-00124
- GENERATOR PULSAR IIDec 12, 2014MalfunctionMedtronic Advanced Energy Llc1226420-2014-00119
- PULSAR II GENERATORNov 24, 2014MalfunctionMedtronic Advanced Energy, Llc1226420-2014-00112
- AQUAMANTYS GENERATORNov 24, 2014InjuryMedtronic Advanced Energy, Llc1226420-2014-00114
- PULSAR II GENERATORNov 24, 2014MalfunctionMedtronic Advanced Energy (salient)1226420-2014-00117
- PULSAR 2 GENERATORNov 13, 2014MalfunctionMedtronic Advanced Energy1226420-2014-00108
- PULSAR 2 GENERATORNov 13, 2014MalfunctionMedtronic Advanced Energy, Llc1226420-2014-00111
Event type breakdown
Malfunction128
Injury21
Product problems
Reported product problem codes, most common first
Device Operates Differently Than Expected43
Electromagnetic Interference20
Insufficient Device Problem Information16
Adverse Event Without Identified Device or Use Problem10
Failure to Shut Off10
Device Displays Incorrect Message7
Use of Device Problem7
Fire6
Trend for “Device Operates Differently Than Expected”
No history to chart.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.