MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ZIP PENCIL 10FT W/0012 UCONN; ZIP PEN SMOKE EVAC PENCIL, E-Z CLEAN

Model Number	252510
Medical Device Problem Codes	Flaked (1246); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Photo analysis: this is an analysis for a set of images submitted to ethicon endo surgery for evaluation.Image 1: the image provided by the customer shows a gauze with some unknown matter.Image 2: the image provided by the customer shows a different non ees instrument used during a surgical procedure.Image 3 and 4:the image provided by the customer shows an electrode with the coating damage.No conclusion could be reached as to how this issue occurred through photo analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.Additional information received: the dhr review is confirmed that the product was produced accomplishing quality requirements and released according to established procedures.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 current status of the patient? how did the mark indent get on the blade?.
Event or Problem Description
It was reported that during a inguinal hernia repair, the ez-clean coating partially detached from the electrode.It was during the test with smoke evacuator pencil.Part of the procedure was tunneled, it can not be excluded that the possibility that the physician touched the electrode with a metal instrument.The electrode was only cleaned with a damp cloth (no abrasive sponge or knife).The customer is familiar with ez-clean electrodes.He has been using them for several years (version 0012m).He has never experienced this before.Disadvantages to the patient included surgical time increased by 10 minutes.The coating particles couldn¿t all be removed and are therefore still in the inguinal canal of the patient.The electrode was immediately removed from the surgical field pictures were taken of the particles just after removal and in the patient.A new smoke evacuator pen with the same reference and lot number was used to finish the procedure.The ez-clean electrode of this pen showed no problem.

• Brand Name: ZIP PENCIL 10FT W/0012 UCONN
• Common Device Name: ZIP PEN SMOKE EVAC PENCIL, E-Z CLEAN
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: kara ditty-bovard ; 11506 south state street; draper 84020 ; 6107428552
• MDR Report Key: 13757690
• Report Number: 1721194-2022-00013
• Device Sequence Number: 11383116
• Product Code: FYD
• UDI-Device Identifier: 10614559105337
• UDI-Public: 10614559105337
• Combination Product (Y/N): N
• PMA/510(K) Number: K141587
• 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
• Report Date (Section B): 03/14/2022

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 Expiration Date: 08/31/2023
• Device Model Number: 252510
• Device Catalogue Number: 252510
• Device Lot Number: 2006154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown