MAUDE Adverse Event Report: ARTHROCARE CORP. CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2019

Event Type  malfunction  

Event Description

It was reported that during a procedure the ablate setting was not working, pedals and wands were switched and device was not working either.The procedure was delayed 30 minutes and it was ended with a e3310 suction coag bovie instead.No patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device used in treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.Review of manufacturing records could not be performed as no lot number or serial number was provided.A complaint history review for lot number/serial number could not be performed as no serial number or part number were provided.No containment or corrective actions are recommended at this time.Without the reported product a visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to ¨ ablate / coag issue / wand does not activate ¨ include, but are not limited to: (1) there may have been a loose foot control assembly or wand connection to the controller which could have caused non-functionality or (2) an issue with the other concomitant devices.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

Manufacturer Narrative

D4: catalog number and serial number updated as unknown.Lot number and expiration date must be empty spaces since it does not apply.H4: device manufacture date must be empty space since it does not apply.

Manufacturer Narrative

H10: a2: patient age around 4 or 5.A3: patient sex added.

Manufacturer Narrative

H10: d4: catalog number, lot number, and expiration date added.H4: device manufacture date added.

• Brand Name: CONTROLLER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9535281
• MDR Text Key: 179943229
• Report Number: 3006524618-2019-00629
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K162074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 2037531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 12/31/2019; 01/21/2020; 02/06/2020; 03/03/2020
• Supplement Dates FDA Received: 01/08/2020; 01/23/2020; 02/26/2020; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1