MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ZIP PENCIL 10FT W/0012 ECONN; ZIP PEN SMOKE EVAC PNCL E-Z CLEAN 22MM

Model Number 252510EC

Device Problem Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that during a diep flap procedure there were big sparks.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2022.Video analysis: this is an analysis of a video submitted to ethicon endo-surgery for evaluation.Video (enernl21-019 video-(b)(6) 2022-(b)(6)): the video provided by the customer shows a 252510ec device being used in a procedure.During the video, flames could be observed when the device touches tissues while is activating.No conclusion could be reached as to how this issue occurred through video analysis.As part of the 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.No batch information was provided for the product evaluated.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: 8/8/2022 additional information provided: they have done a comparative study with their current pens and ours with the following settings: electrosurgery generator: brand: erbe type: vio 300 d year of manufacture/serial number: (b)(6) setting used in the test: spray mode (strength?) coag spray 80w and 100w setting used with patient: spray mode (strength?) high cut 80w effect 2 they indicate that it is probably due to the length of our mouth (shorter than the current pen), which means that more oxygen is added and this can cause flames.These are very high settings, but it seems to be going well with the current pen.

• Brand Name: ZIP PENCIL 10FT W/0012 ECONN
• Type of Device: ZIP PEN SMOKE EVAC PNCL E-Z CLEAN 22MM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 84020
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: orla o'mahony ; 11506 south state street; draper, UT 84020
• MDR Report Key: 14590618
• MDR Text Key: 301038001
• Report Number: 1721194-2022-00058
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559105344
• UDI-Public: 10614559105344
• Combination Product (y/n): N
• PMA/PMN Number: K141587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 252510EC
• Device Catalogue Number: 252510EC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1