MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. TELESCOPE SMOKE DISSECTOR STD; RETURN ELECTRODE CABLE, DUAL PLATE

Catalog Number	ME7251ST
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 3/17/2026 b3: event year only reported: 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.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: which tissue showed the blistering & signs of decreased vascularization and where was it located? were the tissue issues a burn? if yes, what was the degree of severity of the burn? what was the location of the affected issue in relationship to where the pencil (me7251st) was used? are photos of the blistering (possible burn) available for review? are photos of the pencil device (me7251st) available for review? at what point during the reconstruction portion of the procedure were the tissue issues observed? was there any damage to the pencil (me7251st) that was noticed? does the surgeon believe there is an alleged deficiency to the pencil that caused or contributed to the blistering and decreased vascularization? did the mastectomy procedure team or plastic surgeon team report this issue? were both operating teams using the same devices in both parts of the surgery (mastectomy & reconstruction)? what products were used at each point of the procedure? what power level was the generator set to? is the device available for jnj analysis? what were the issues the patient developed postoperatively? were the postoperative issues caused or contributed by the me7251st? what is the patient¿s current status? an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 mastectomy procedure performed by the surgical team, a plastic surgeon was brought in to complete the reconstruction using a soft tissue dissector.Upon assessment, the plastic surgeon noted areas of blistering and mild signs of decreased vascularization within the tissue.Despite these findings, the reconstruction was completed without intraoperative complications.Postoperatively, the patient developed issues related to the viability of the reconstructed tissue.Due to these complications, the clinical team determined that the patient would need to return to the operating room for revision surgery and a redo of the flap.

• Brand Name: TELESCOPE SMOKE DISSECTOR STD
• Common Device Name: RETURN ELECTRODE CABLE, DUAL PLATE
• 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: 24617267
• Report Number: 1721194-2026-00011
• Device Sequence Number: 10333885
• Product Code: GEI
• UDI-Device Identifier: 10614559105955
• UDI-Public: 10614559105955
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982130
• 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
• Report Date (Section B): 03/17/2026

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: ME7251ST
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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