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

Catalog Number	0035H
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 11/13/2023.B3: only event year known: 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.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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.
Event or Problem Description
It was reported that during an seminal vesicles procedure the needle point tip within the pencil sparked a fire on scar tissue on first activation.No patient harm.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/18/2023.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.The manufacturing records were reviewed and the manufacturing, packaging criteria were met prior to the release of this lot.

• Brand Name: E-Z CLEAN PNCL BTN HLSTR
• Common Device Name: 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: 18121301
• Report Number: 1721194-2023-00131
• Device Sequence Number: 6988721
• Product Code: GEI
• UDI-Device Identifier: 10614559100493
• UDI-Public: 10614559100493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K965054
• 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): 12/18/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0035H
• Device Lot Number: 2209017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown