MAUDE Adverse Event Report: ARTHROCARE CORP. PROCISE EZ VIEW COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EIC8875-01

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Information (3190)

Event Date 08/07/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, the wand kept losing its cauterization power for a few seconds at a time and then it would begin to work again.Another wand was opened but the same issue happened.The procedure was successfully completed with an unknown delay using another method of cauterization.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found do not contact metal objects such as a mouth gag while activating the plasma wand.It may damage the wand tip, the wand shaft insulation, or cause malfunction, or injury may result.Damaged insulation could lead to unwanted electrical conduction resulting in patient burns.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during a tonsillectomy with adenoidectomy procedure, the wand kept losing its cauterization power for a few seconds at a time and then would begin to work again.The procedure was successfully completed without significant delay using another method of cautery.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: additional information.In b5.

• Brand Name: PROCISE EZ VIEW COBLATOR II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10544636
• MDR Text Key: 207283411
• Report Number: 3006524618-2020-00780
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000313
• UDI-Public: 00817470000313
• Combination Product (y/n): N
• PMA/PMN Number: K070374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Model Number: EIC8875-01
• Device Catalogue Number: EIC8875-01
• Device Lot Number: 2032432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention