MAUDE Adverse Event Report: ARTHROCARE CORP. CII (120V) SRVC, CONTROLLER-ONLY PACKAGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 13546-59S

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Event Description

It was reported that during a tonsillectomy, the controller was functioning slower and not coaging vessels as usual.The procedure was completed with the same device and no delay was reported.The patient had post operative bleeds about 7-10 days after surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and observed no issues.A functional evaluation revealed no problems.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.No clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Should any additional clinical information be provided this complaint will be re-evaluated.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please select the wand type most appropriate for the procedure.The controller will preset nominal and maximum coblate and coagulation voltages for each wand style to ensure a safe effective operation.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

Manufacturer Narrative

H10: additional information on b5.

Event Description

It was reported that during a tonsillectomy, the controller was functioning slower and not coaging vessels as usual.The procedure was completed with the same device and no delay was reported.The patient had post operative bleeds about 7-10 days after surgery and treated with suction cautery to coagulate the bleeding vessels.

• Brand Name: CII (120V) SRVC, CONTROLLER-ONLY PACKAGE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9638946
• MDR Text Key: 176685699
• Report Number: 3006524618-2020-00033
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 13546-59S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 02/04/2020; 05/14/2020
• Supplement Dates FDA Received: 02/05/2020; 05/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other