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
| Device | RF12000 Q2 SRVC, CONTROLLER-ONLY PACKAGE |
|---|---|
| Generic name | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
| Manufacturer | ARTHROCARE CORP. |
| Report number | 3006524618-2020-00219 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | IT 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. |
| Source | openFDA MAUDE (device adverse events) |
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