MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BALL 5IN; E-Z CLEAN BALL 5 INCH

Model Number	0009
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested, and the following was obtained: could you please confirm if the insulation missed fell off inside the patient? what is the current status of the patient? answer = patient did not experience any issues and has not come back with complications/problems.The customer does not see it as a risk if the piece would have fallen off during the procedure (probably came out already then) and has not intended to call in the patient for a check up.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: we need to know if the surgeon believes that the detached insulation piece was fallen into the patient and was not retrieved.Was the detached insulation piece fallen into the patient and not retrieved (yes or no)? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, a problem was detected after surgery, part of insulation missing and could not be found.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/27/2021.The product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.During the visual inspection, the tip of the electrode was found burnt and the metal was melted.The further evaluation found a hole in the insulation on the electrode which was exposing the metal shaft.Due to the condition of the electrode no functional testing could be performed.It should be noted that product failure is multifactorial.The most likely cause of the melting and burnt areas of the tip of the electrodes is due to the device being used in an excessive high-power setting and prolonged activations during use.The most likely cause of the insulation damage is due to the device being damaged by sharp objects or other devices.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Additional information was requested, and the following was obtained: was the detached insulation piece fallen into the patient and not retrieved (yes or no)? no more information can be obtained.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/9/2021.Correct data on mwr-20042021-0000942269: h6 testing of actual/ suspected device (b01).

• Brand Name: E-Z CLEAN BALL 5IN
• Common Device Name: E-Z CLEAN BALL 5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 11626942
• Report Number: 1721194-2021-00025
• Device Sequence Number: 3667703
• Product Code: GEI
• UDI-Device Identifier: 10614559100042
• UDI-Public: 10614559100042
• Combination Product (Y/N): N
• PMA/510(K) Number: K862221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 0009
• Device Catalogue Number: 0009
• Device Lot Number: 200442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 06/08/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/27/2021; 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1