MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN PNCL BTN HLSTR; E-Z CLEAN PENCIL BUTTON HOLSTER

Catalog Number 0035H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/11/2023

Event Type  Injury  

Event Description

It was reported that during a femoral procedure the device burned the patient on the incision site.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 9/6/2023.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.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: what is the severity of the burn? (please see degrees of burns below and choose one).First degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters.Second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful.Third degree burn the burn site looks deep, whitening or blackened and charred.What medical intervention was used to treat the burn? (such as salve or stitches).Besides the burn, did the patient experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? answer: according to the surgeon, it was a second degree burn that was treated with topical silvadene.He doesn¿t anticipate any long term injury.It was a small dermal burn.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)(6).Does the surgeon believe there is an alleged deficiency to the device that led to patient burn and if so why? when were the burns first noticed? where is the burn located on the patient? what is the current status of the patient? what was the surgical procedure? how long did the surgical procedure last? is it possible the patient was in contact with a metal portion of the or table? what generator was being used? what power levels was generator set to? was there any diminished effect of the generator noted during the surgery? what is the age of the patient? was there any damaged to the pencil or electrode? was the pencil placed into the holster between uses? 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: 9/21/2023.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 0035h device was returned with the electrode attached, upon visual inspection, the electrode was observed with the tip melted and charred.In addition, it was noted a blue material melted in the electrode.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.It is possible that this issue could have caused the event reported.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot: 2211185 and no non-conformances were identified.

• Brand Name: E-Z CLEAN PNCL BTN HLSTR
• Type of Device: E-Z CLEAN PENCIL BUTTON HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17689881
• MDR Text Key: 322719544
• Report Number: 1721194-2023-00108
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559100493
• UDI-Public: 10614559100493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0035H
• Device Lot Number: 2211185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention