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

Model Number 72290038

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

Werewolf handpieces are not working in the werewolf machine.Rep called & came in and stated the generators were working; it was the handpieces that were defective.Apparently other hospitals have complained as well.Both handpieces we opened were of different lot numbers.The error message reads, "error wand has passed its expiration date.Replace wand"; however, the wands were not out of date.Pulled all handpieces off the shelf for rep to replace them.There were no notifications from the company of potential issues with these probes.

• Brand Name: COBLATION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 150 minuteman road; andover MA 01810
• MDR Report Key: 15292656
• MDR Text Key: 298573133
• Report Number: 15292656
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2022,05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 72290038
• Device Catalogue Number: 72290038
• Device Lot Number: 2087448
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2022
• Date Report to Manufacturer: 08/25/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1