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RF12000 Q2 SRVC, CONTROLLER-ONLY PACKAGE Adverse Event — Injury (MDR 3006524618-2020-00219)

RF12000 Q2 SRVC, CONTROLLER-ONLY PACKAGE Adverse Event — Injury (MDR 3006524618-2020-00219) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RF12000 Q2 SRVC, CONTROLLER-ONLY PACKAGE; Generic name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES; Manufacturer: ARTHROCARE CORP

DeviceRF12000 Q2 SRVC, CONTROLLER-ONLY PACKAGE
Generic nameELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
ManufacturerARTHROCARE CORP.
Report number3006524618-2020-00219
Event typeInjury
Product problemN
Date received2020-04-27
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativeIT WAS REPORTED THAT DURING A PROCEDURE CONTROLLER HAD A F4 HARDWARE ERROR. PROCEDURE WAS COMPLETED WITH A MITEK COMPETITOR DEVICE INSTABILITY WITH ANTERIOR PORTAL TO RELEASE THE CAPSULE, NO DELAY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
SourceopenFDA MAUDE (device adverse events)

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