MAUDE Adverse Event Report: ARTHROCARE CORP. REFLEX ULTRA PTR COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EIC4835-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a septo/fess procedure, the metal end of the reflex ultra wand snapped off and half the silver part of the coabaltor was inside the patient.Back up device was available to complete the surgery.No significant surgical delay was reported.No further complications were reported.
Event or Problem Description
It was reported that during a septo/fess procedure, the half silver/metal part of the reflex ultra wand snapped off from the blue part of the ablator, when it was inside the patient.Back up device was available to complete the surgery.No significant surgical delay was reported.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned instrument shows no manufacturing abnormalities.The shaft is bent where it meets the handle.The electrode has been detached.Product was out of the original packaging.No packaging returned.The device was plugged into the controller and registered settings (4,2).The wand was not able to generate plasma and coagulation due to damaged shaft.A review of the customer provided image shows a wand in the original packaging and confirming part and lot number.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) excessive force.Based on a review of the complaint, it is unknown if ¿half the silver part of the coblator¿ was retained/recovered from the patient.Reportedly, the device packaging and the device was intact prior to opening the packaging.The material composition for the wand is commercially pure (99.95% or greater purity) molybdenum.The coblation wands are manufactured and intended as externally communicating devices and are not approved for long-term internal tissue exposure and long-term implantation data is not available.Consequently, we are unable to make any conclusions on the impact of the possibly retained non-implantable foreign body.However, if the half silver part of the coblator, was retained inside of the patient¿s body, the potential for micro-motion and/or migration, and local skin irritation/discomfort cannot be rule out.It was reported the procedure was completed with a back-up device with a non-significant delay.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.Correction in d4, unique identifier (udi).

• Brand Name: REFLEX ULTRA PTR COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14724679
• Report Number: 3006524618-2022-00297
• Device Sequence Number: 5800475
• Product Code: GEI
• UDI-Device Identifier: 00817470005455
• UDI-Public: 00817470005455
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: EIC4835-01
• Device Catalogue Number: EIC4835-01
• Device Lot Number: 2064393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown