MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. PNCL 12 USE BTN HLSTR 10FT CORD; PENCIL 12 USE BUTTON HOLSTER 10 FT CORD

Catalog Number	3035H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/5/2019.Batch # unk.Investigation summary: one each 3035h unknown lot number was returned for evaluation.The device was functionally tested and found to be performing within specifications.No abnormalities were found during visual inspection.The complaint is unconfirmed.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Additional Manufacturer Narrative
(b)(4).Batch # unknown.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.
Event or Problem Description
It was reported that during an abdominal procedure that the device turned on when button was not depressed.A similar device was used to complete the case.There were no adverse patient consequences.

• Brand Name: PNCL 12 USE BTN HLSTR 10FT CORD
• Common Device Name: PENCIL 12 USE BUTTON HOLSTER 10 FT CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9156353
• Report Number: 1721194-2019-00122
• Device Sequence Number: 13527368
• Product Code: GEI
• UDI-Device Identifier: 10614559102541
• UDI-Public: 10614559102541
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 3035H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1