MAUDE Adverse Event Report: ARTHROCARE CORP. EVAC 70 XTRA COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EIC5872-01

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Information (3190)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported that during an adenotonsillectomy surgery the probe got blocked a few minutes after the surgery started and could not ablate from that point.No significant delay or other complication were reported.Surgery was completed using a competitor device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h6.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 found no related failures; this failure mode will be trended to assess for any necessary corrective actions.A review of the instructions for use found: monitor the saline flow during the procedure.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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.

• Brand Name: EVAC 70 XTRA COBLATOR II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10835970
• MDR Text Key: 216119983
• Report Number: 3006524618-2020-00992
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003185
• UDI-Public: 00817470003185
• Combination Product (y/n): N
• PMA/PMN Number: K070374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: EIC5872-01
• Device Catalogue Number: EIC5872-01
• Device Lot Number: 2042166
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 68