MAUDE Adverse Event Report: ARTHROCARE CORPORATION PROCISE XP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number EIC8872-01

Device Problem Break (1069)

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

Event Date 03/23/2024

Event Type  malfunction  

Event Description

It was reported that during an ent procedure, after opening the precise wand package and using it for 5 minutes, the electrode wire broke.The broken pieces were removed from the patient using suction.The procedure was successfully completed using a back-up device.There was a surgical delay less than 30 minutes and no further complications were reported.

Manufacturer Narrative

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

• Brand Name: PROCISE XP COBLATOR II
• 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: 19122233
• MDR Text Key: 341241495
• Report Number: 3006524618-2024-00146
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000368
• UDI-Public: 00817470000368
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EIC8872-01
• Device Lot Number: 2128632
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2024
• Date Device Manufactured: 08/07/2023
• 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
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 19 KG