MAUDE Adverse Event Report: ARTHROCARE CORPORATION UNKNOWN COBLATION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It was reported that during tonsillectomy and adenoidectomy, three (3) evac 70 coblator wands and one (1) foot pedal were not working correctly.The handpiece was replaced 3 times, and the foot pedal once.The procedure was completed with a delay greater than 30 minutes using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference number: (b)(4).D4, lot no.: the following are the part numbers & lot numbers reported: part number: eica5874-01/lot number: 2130647 (2 devices), part number: eica5874-01/lot number: 2129111 (1 device), and part number: unknown system 2000 controller/lot number: unknown (1 device), however, it is unknown which of the 4 devices contributed with the delay greater than 30 minutes.D4, exp.Date: expiration dates for each of the 2 lot numbers reported: 12-sep-2026 (2 devices: eica5874-01/lot number: 2130647) & 31-aug-2026 (1 device: eica5874-01/lot number: 2129111).H4, mgf.Date: manufacturing dates for each of the 2 lot numbers reported: 12-sep-2023 (2 devices: eica5874-01/lot number: 2130647) & 31-aug-2023 (1 device: eica5874-01/lot number: 2129111).D1: brand name was changed to unknown due to the two part numbers reported: eica5874-01 & unknown system 2000 controller.

Manufacturer Narrative

H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKNOWN COBLATION DEVICE
• 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: 18608981
• MDR Text Key: 334416175
• Report Number: 3006524618-2024-00036
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470004007
• UDI-Public: 00817470004007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 02/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Sex: Female