MAUDE Adverse Event Report: ARTHROCARE CORPORATION EVAC 70 XTRA HP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number EIC5874-01

Device Problem Energy Output Problem (1431)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a tonsillectomy, an evac coblator ii wand was employed on a male adult patient.Due to a leakage of energy from the medial portion of the device, the tongue and oral commissure got ulcerated.The reported ulceration required continued antibiotics and h2o2 wash for healing and soothing.The procedure was completed using a back-up device.There was a surgical delay less than 30 minutes and no further complications were reported.As of (b)(6) 2024, the patient still has a non-healing ulceration in the tongue and cosmetic deformity of the lower lip.

• Brand Name: EVAC 70 XTRA HP 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: 18982066
• MDR Text Key: 338659940
• Report Number: 3006524618-2024-00125
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470004595
• UDI-Public: 00817470004595
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EIC5874-01
• Device Lot Number: 2124062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Date Device Manufactured: 06/09/2023
• 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 Outcome(s): Required Intervention; Other
• Patient Sex: Male