MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE 2.75IN BNS; E-Z CLEAN BLADE 2.75 INCH BNS

Model Number	0012ABN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown; captured as awareness date.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Photo analysis: this is a photo analysis for a set of images submitted to ethicon endo surgery for evaluation.Images 1-3: the images provided by the account is of what appears to be an e-z clean blade 2.75in bns.The insulation appears to be detached from the electrode.It should be noted product failure is multifactorial.No conclusion could be reached as to how this issue occurred through photo analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: were unintended fragments generated and fell into the patient? no ¿ issue was found prior to use.If so, were they completely removed without additional procedures? na.Did the patient experience any adverse consequences due to this issue? if yes, please specify.No.No sample to return.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, that the cautery tip failed.

• Brand Name: E-Z CLEAN BLADE 2.75IN BNS
• Common Device Name: E-Z CLEAN BLADE 2.75 INCH BNS
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 11222579
• Report Number: 1721194-2021-00006
• Device Sequence Number: 10932040
• Product Code: GEI
• UDI-Device Identifier: 10614559103647
• UDI-Public: 10614559103647
• Combination Product (Y/N): N
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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 Model Number: 0012ABN
• Device Catalogue Number: 0012ABN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1