MAUDE Adverse Event Report: ARTHROCARE CORP. COVAC 70 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASC3730-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy when the wand was plugged in it did not respond, the message "connect wand" remained on screen.It was plugged out and in again and the same issue happened.The procedure was completed with a backup device, no delay or patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
¿h10 h3, h6: the device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found no related failures.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: 1) there may have been an issue with the device that did not allow it to connect fully to the controller (e.G.Bent pin).2) there may have been an issue with a concomitant device used at the time of the complaint event.There are no indications to suggest the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H3,h6: the device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.Visual inspection of the device showed minimal erosion of the electrodes and some contamination and bent pins in the connector.The device was unable to be connected to a known good controller as the device's pins were bent.The complaint was verified.Factors, which may have contributed to the reported complaint include: (1) misalignment or connecting the wand to the unintended port which could have caused damage to the pin.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: COVAC 70 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10210378
• Report Number: 3006524618-2020-00424
• Device Sequence Number: 16671105
• Product Code: GEI
• UDI-Device Identifier: 00817470004700
• UDI-Public: 00817470004700
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ASC3730-01
• Device Catalogue Number: ASC3730-01
• Device Lot Number: 2015461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/21/2020; 11/03/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/28/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1