MAUDE Adverse Event Report: ARTHROCARE CORP. REFLEX ULTRA 45 COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EIC4845-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using reflex ultra 45 coblator ii, the coating at the end of the wand peels off and it took time to find the missing silicon pieces the procedure was completed with the same device within a delay shorter than 30 minutes with no further complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.Although it was communicated that the user of the device spent a lot of time finding the missing silicon pieces no patient injuries are being reported due to the additional surgical time.The procedure was completed using the same device.Since no patient injuries or adverse consequences were reported.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found a related failure; this failure mode will be trended to assess for any necessary corrective actions.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Risk management documents review found no additional risks that require to be added to the reference document.No further additional actions are required at this time.Visual inspection revealed moderate erosion of electrodes and contamination around the tip.Insulation chipped.Bent tip.The device was plugged into a known good controller.Functional evaluation revealed that while the device fired, the glow of the ablate function was lower than expect on default and maximum settings.Coagulate performed as intended.The complaint was verified as the device's insulation was chipped and the electrode was weaker than expected.The root cause was determined to be component failure.Factors, which may have contributed to the reported complaints include: 1) the bent tip may have cause the weaker glow of plasma.2) the insulation may have been cracked due to coming into contact with a hard surface, such as a cannula.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: REFLEX ULTRA 45 COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10131282
• Report Number: 3006524618-2020-00344
• Device Sequence Number: 19282773
• Product Code: GEI
• UDI-Device Identifier: 00817470004212
• UDI-Public: 817470004212
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K033257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EIC4845-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1