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

Model Number	0039H
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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 unknown procedure, the device threw off the electric sparks.Next (b)(6) medicalnext¿s electric knife was used with the device.The setting voltage was 45·45, 40·40 when it sparked.Competitive generator was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4), date sent: 10/5/2021 additional information received: new deantronics stated: the dhr review is confirmed that the product was produced accomplishing quality requirements and released according to established procedures.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/26/2021.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.The device was returned with no apparent damage.The device was functionally tested with a multimeter and meets the specification, no abnormalities were observed.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.The batch history records were reviewed and certified by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.The certificate records are accessible through external manufacturing.

• Brand Name: NON COATED PNCL BTN HLSTR
• Common Device Name: NON COATED PENCIL BUTTON HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 12482385
• Report Number: 1721194-2021-00071
• Device Sequence Number: 17079938
• Product Code: GEI
• UDI-Device Identifier: 10614559100868
• UDI-Public: 10614559100868
• Combination Product (Y/N): N
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2021

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 Expiration Date: 02/28/2025
• Device Model Number: 0039H
• Device Catalogue Number: 0039H
• Device Lot Number: 1807220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/21/2021; 10/06/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/05/2021; 10/26/2021
• Patient Sequence Number: 1