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

Catalog Number	0100
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	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lap hysterectomy, when using the megadyne ez clean electrode code 0100 the black sheath came apart from the electrode tip.Used another tip to complete case used another electrode.There was no surgical delay.The procedure was successfully completed.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4) date sent: 12/13/2023 b3: exact date is unk.Assumed 1st day of the month.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/9/2024.Investigation summary: the product was returned for evaluation.Visual inspection were conducted on the returned device.Visual analysis of the returned electrode determined that the 0100 device was returned with a cut in the insulation at the distal end, exposing the metal substrate and not detached as reported.The most likely cause of this damage is a result of the application of excessive mechanical forces such as contact with other instruments or objects that damage the edge of the insulation.For instance, contact with a sharp edge on the trocar during insertion or removal may cut or slice the insulation.Subsequent use contributes to the continued ¿splitting¿.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch tdmbcb, and no non-conformances were identified.

• 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.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18317991
• Report Number: 1721194-2023-00138
• Device Sequence Number: 6152678
• Product Code: GEI
• UDI-Device Identifier: 10614559100660
• UDI-Public: 10614559100660
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0100
• Device Lot Number: TDMBCB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown