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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 9/4/2024.D4 batch # unk.B3: exact date is unk.Assumed first 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 lot.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: what efforts were made to locate the pieces of the coating of the electrode during the procedure? was this procedure converted to an open procedure? are there any plans to locate the pieces? was there any change in the patient care as a result of this event? what is the current patient status? 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.
Event or Problem Description
It was reported that during a cholecystectomy the coating below the l electrode comes off intraoperatively and remains in the patient.No report of patient harm.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/11/2024.Additional information was requested, and the following was obtained: ¿ what efforts were made to locate the pieces of the coating of the electrode during the procedure? the device was used as usual.¿ was this procedure converted to an open procedure? no, the device has been replaced.¿ are there any plans to locate the pieces? the pieces were removed intraoperatively.¿ was there any change in the patient care as a result of this event? nothing knows.¿ what is the current patient status? no information about it.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/3/2024.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/21/2024.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned electrode determined that the 0100 device was returned with tears in the insulation at the distal end and not detached.The instrument was tested for continuity and passed the test.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.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 lot uamptu, 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 ; 3035526892
• MDR Report Key: 20134200
• Report Number: 1721194-2024-00073
• Device Sequence Number: 15291335
• Product Code: GEI
• UDI-Device Identifier: 10614559100660
• UDI-Public: (01)10614559100660(17)281231(10)UAMPTU
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup,Followup
• Report Date (Section B): 11/21/2024

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 Catalogue Number: 0100
• Device Lot Number: UAMPTU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 09/26/2024; 11/20/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/11/2024; 10/03/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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: Required Intervention
• Patient Sex: Unknown