MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN L-WIRE LAP 33CM; E-Z CLEAN WIRE L-WIRE LAP 33 CM

Model Number	0100
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 0100 device b was returned with the coating damage.However, the insulation was not detached.The instrument was tested for continuity and pass the test.Occasionally, damaged to the coating occurs when the blade is exposed to metal contact and/or high heat/prolonged activations without tissue.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.No lot or batch were provided, bhr could not be performed.Additional information was requested, and the following was obtained: when the device was received for (b)(4), 2 product codes 0100 were received.On the initial complaint for 1 of the 0100, it was stated ¿the device was 'bent' and the outer layer is split in half and insulation of the tip of the l hook was detached and bend backwards¿.What was the issue with the second 0100 that was returned? the issue of the second device is the same as the first one.Did the second 0100 have the same issue as the first 0100? yes.Did the patient experience any adverse consequences due to this issue? if yes, please specify and inform what was done to help the patient.No.Could you please confirm which part of the device ¿'bent¿? the part bent detached from the device? insulation of the tip of the l hook was detached and bend backwards.What do you mean with ¿outer layer¿? is the insulation? is the handle? the outer layer insulation of the l tip hook was detached and bend backwards.
Event or Problem Description
It was reported that during an unknown procedure the device was 'bent' and the outer layer is split in half.

• Brand Name: E-Z CLEAN L-WIRE LAP 33CM
• Common Device Name: E-Z CLEAN WIRE L-WIRE LAP 33 CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 12078826
• Report Number: 1721194-2021-00055
• Device Sequence Number: 19814823
• Product Code: GEI
• UDI-Device Identifier: 10614559100660
• UDI-Public: 10614559100660
• Combination Product (Y/N): N
• PMA/510(K) Number: K913281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

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: 0100
• Device Catalogue Number: 0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/28/2021
• Patient Sequence Number: 1