MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. REUSE LAP ELEC SHAFT FOOT 32CM; REUSABLE LAP ELECTRODE SHAFT FOOT 32CM

Model Number	0690S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: (b)(6) 2021.Unknown; captured as awareness date.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information received: opened up trays to make sure completion prior to opening hospital for surgeries and noticed the yellow layer under the insulation exposed.Additional information was requested, and the following was obtained: did the patient experience any adverse consequences due to this issue? if yes, please specify and inform what was done to help the patient? this unit was never used in a surgery.Not applicable.
Event or Problem Description
It was reported that during an unknown procedure the device is defective.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/6/2021.The product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the 0690s device was received with piece of the insulation detached not returned.Also observed the insulation has damaged areas at the proximal end were the insulation has been scraped.This damage is consistent with the devices coming in contact with other instrumentation.The complaint is confirmed.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: REUSE LAP ELEC SHAFT FOOT 32CM
• Common Device Name: REUSABLE LAP ELECTRODE SHAFT FOOT 32CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 12065694
• Report Number: 1721194-2021-00053
• Device Sequence Number: 3925888
• Product Code: GEI
• UDI-Device Identifier: 10614559101247
• UDI-Public: 10614559101247
• Combination Product (Y/N): N
• PMA/510(K) Number: K943055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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 Model Number: 0690S
• Device Catalogue Number: 0690S
• Device Lot Number: 195737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1