MAUDE Adverse Event Report: ARTHROCARE CORPORATION SUPER TURBOVAC 90 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number ASC4250-01

Device Problem Material Separation (1562)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an unspecified arthroscopy, the leaflet at the tip of the super turbovac 90 has detached in the middle after a short time.The procedure was completed with a s+n back up device.There was a delay less than 30 minutes and no further complications were reported.

• Brand Name: SUPER TURBOVAC 90 ICW
• 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: 18898197
• MDR Text Key: 337595655
• Report Number: 3006524618-2024-00096
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470006421
• UDI-Public: 00817470006421
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033584
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2023
• Device Catalogue Number: ASC4250-01
• Device Lot Number: 2137312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Date Device Manufactured: 11/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1