MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. NON COATED PNCL RKR HLSTR; NON COATED PENCIL ROCKER HOLSTER

Model Number	0038H
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an appendectomy the bovie arced no steps were taken to adjust settings.
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.No lot or batch number was provided therefore a device history could not be done.Additional information received: the generator was turned down for the settings, but it did not help.It happened regardless of procedure type, bovie type etc.Biomed check this unit and it tested the same as when received in february but on the higher end of tolerance.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/7/2022.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.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: could you please help us to clarify the bovie arced mentioned in the complaint happened in which part of the product? blade or plastic pen body?.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/21/2022.See attached report.

• Brand Name: NON COATED PNCL RKR HLSTR
• Common Device Name: NON COATED PENCIL ROCKER HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15252329
• Report Number: 1721194-2022-00071
• Device Sequence Number: 20468179
• Product Code: GEI
• UDI-Device Identifier: 10614559100844
• UDI-Public: 10614559100844
• 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,Followup
• Report Date (Section B): 11/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 0038H
• Device Catalogue Number: 0038H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 11/10/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/07/2022; 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown