MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN 4.75IN BLD CUST MOD; E-Z CLEAN BLADE MOD CUSTOM 4.72 INCH

Catalog Number	C117M
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	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an open chest/ abdomen for lateral lymph node dissection, salpingo-oophorectomy, and hysterectomy, it was found that the tip was deformed during surgery.At the doctor's discretion, extensive cleaning and checking with a c-arm, no missing parts were found, but the wound was closed as is.The surgeon had no memory of hitting it or any interference from metal.The opinion in the operating room was that it may have melted.The burnt parts have solidified and it looked to be missing, but the missing part has not been found when the device was checked.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/30/2026.D4 batch#: unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information was requested and the following was obtained: are additional procedures considered? no additional procedures.Is the patient in good condition after the surgery? the patient is stable.There is no problem.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 lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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: 2/11/2026.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 is the make, model, and serial number of the generator that was used in this procedure? investigation summary the product was returned for evaluation.Visual analysis of the returned sample determined that the device was returned with the tip of the electrode melted and charring present.In addition, instrumentation marks were also observed on the insulation.Due to this condition the event reported was confirm.Additionally, photos were provided and they showed the condition of the reported event.The most likely cause of this damage is caused by operating the electrosurgery equipment (generator) at high power settings with continual activation of the electrode for long periods or by placing the electrode tip against another instrument causing extreme heat which results in the melting of the tip.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.No lot or batch were provided, bhr could not be performed.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/18/2026.Additional information was requested and the following was obtained: what is the make, model, and serial number of the generator that was used in this procedure? unk.

• Brand Name: E-Z CLEAN 4.75IN BLD CUST MOD
• Common Device Name: E-Z CLEAN BLADE MOD CUSTOM 4.72 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 24223776
• Report Number: 1721194-2026-00002
• Device Sequence Number: 9273368
• Product Code: GEI
• UDI-Device Identifier: 10614559103326
• UDI-Public: 10614559103326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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: C117M
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/05/2026; 02/16/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/11/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown