MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT REPLACEMENT CORD; MEGA SOFT REPLACEMENT CORD

Model Number	M2K07
Medical Device Problem Codes	Fire (1245); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ambilocal hernia repair procedure, the cable broke and then burned.It burnt the draw sheet and hover pad.It did not burn the patient.This was discovered at the end of the case when it was completed.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
(b)(4).No lot or batch number was provided therefore a device history could not be done.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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: 1/17/2023.Photo analysis: this is an analysis of a set of images submitted for evaluation.Images 1 and 2: the images provided by the customer show burn marks on the draw sheet and hover pad.Image 3: the image provided by the customer shows a pigtail cable broken with burn marks near the connector area.No conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.

• Brand Name: MEGASOFT REPLACEMENT CORD
• Common Device Name: MEGA SOFT REPLACEMENT CORD
• 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: 15958165
• Report Number: 1721194-2022-00116
• Device Sequence Number: 5229457
• Product Code: GEI
• UDI-Device Identifier: 10614559105238
• UDI-Public: 10614559105238
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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: M2K07
• Device Catalogue Number: M2K07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown