MAUDE Adverse Event Report: ARTHROCARE CORPORATION COBLATOR II CONTROLLER (240V); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 13546-02

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during an ent procedure, a coblator ii controller coagulation mode was not working.Surgery resumed after a delay greater than 30 minutes with a change in the surgical technique.No further complications were reported.

• Brand Name: COBLATOR II CONTROLLER (240V)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18970976
• MDR Text Key: 338511255
• Report Number: 3006524618-2024-00121
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 00817470002164
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13546-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1