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

Catalog Number 251010J

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 10/30/2023

Event Type  Injury  

Event Description

It was reported that during a lung wedge resection procedure that while using a bovie the surgeon had his finger under some tissue while cutting and cauterizing and usually he can feel the heat getting stronger the closer he gets to his finger but this time he did not feel it till he had hit his index finger resulting in a blister and a third degree burn.There were no adverse consequences for the patient.Surgeon confirmed that he did not hear any warnings during the case.

Manufacturer Narrative

(b)(4).Date sent: 11/9/2023.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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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: are there any photos of the burn (s) that you could share with us in regards to the burn? if yes, please send to (b)(4).Does the surgeon believe there is an alleged deficiency to the pencil that led to patient burn and if so why? what medical intervention was used to treat the burn (such as salve or stitches)? besides the burn, did the surgeon experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? what is the current status of the surgeons finger? what generator was being used? what power levels was generator set to? was there any diminished effect of the generator noted during the surgery? the information stated ¿surgeon confirmed that he did not hear any warnings during the case¿.What warnings did the surgeon expect to hear? 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.

Manufacturer Narrative

(b)(4).Date sent: 12/1/2023.Additional information was requested, and the following was obtained: does the surgeon believe there is an alleged deficiency to the pencil that led to patient burn and if so why? he assumes since he has not had that happen previously, though nothing prior alerted him to any issue.What medical intervention was used to treat the burn (such as salve or stitches)? none.Besides the burn, did the surgeon experience any adverse consequence due to the issue? none.Are there any anticipated long-term effects from the burn or injury? no.What is the current status of the surgeons finger? still has red sore.What generator was being used? intuitive davinci.What power levels was generator set to? 6.Was there any diminished effect of the generator noted during the surgery? no.The information stated ¿surgeon confirmed that he did not hear any warnings during the case¿.What warnings did the surgeon expect to hear? he didn't expect to hear warnings.I asked him if there were any previous warnings emitted from the generator that may have caused the issue, ie sticky pad coming off or similar.No photos are available.

• Brand Name: 10FT SMOKE PENCIL UCONN
• Type of Device: 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: 18101342
• MDR Text Key: 327729077
• Report Number: 1721194-2023-00129
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105573
• UDI-Public: 10614559105573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 251010J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention