MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. 10FT SMOKE PENCIL UCONN; RETURN ELECTRODE CABLE, DUAL PLATE

Catalog Number	251010J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post op to a panniculectomy case the patient had issues with postoperative bleeding.The surgeon had recently adopted the megadyne smoke evacuation pencil, and is concerned that it may be a factor in the complications.Patient did require revision surgery or hardware removal.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/6/2024 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: as the serial 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.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: 2 devices used.One side used 40cut/35 coag, the other side used 40 cut/50 coag.The surgeon reported bleeding from midline and the 40/35 side.Were there any generator alert screens during the procedure? no alert screens.What anatomical structures was the pencil used on? perforating (subcutaneous) vessels during panniculectomy what was the source of the bleeding and how was it addressed? bleeding vessel causing a hematoma.Required reoperation.How was the pencil used during the procedure? as a dissector and coagulator.Was this pencil the only device used for coagulation during the original procedure or was another device used? if another device was used, what device? a harmonic focus + was used to coagulate several of the larger vessels.Why does the surgeon believe the pencil is a factor in the patient¿s post-operative bleeding? he stated that he thinks that it is too effective as a dissector, and that because it is more efficient, it goes through tissue too quickly and doesn¿t have as much time to coagulate, whereas the stryker pencil is more difficult to get through tissue, so spends more time coagulating.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.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: 8/14/2024.Additional information was requested, and the following was obtained: what was the total estimated blood loss (ml)? 1500.Was a transfusion required? no.How long has the surgeon been using 251010j? 4 months.What is the return electrode that was being used (product code)? conmed ref# (b)(4).Have they recently adopted other megadyne products to the account and if so what are they? no.What generator was used? medtronic ft-10.

• Brand Name: 10FT SMOKE PENCIL UCONN
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 19922459
• Report Number: 1721194-2024-00070
• Device Sequence Number: 7244285
• Product Code: GEI
• UDI-Device Identifier: 10614559105573
• UDI-Public: 10614559105573
• 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,Followup
• Report Date (Section B): 08/14/2024

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: 251010J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/14/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown