MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. LAP MEGATIP ONLY L-WIRE; LAPAROSCOPIC MEGATIP ONLY L-WIRE

Model Number	0600
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	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2020.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot/batch/serial number was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: was there any change in patient care as a result of this event? what is the current patient status? were there any patient consequences due to this event? answers= no change in patient care, the patient has been discharged and no consequences or harm from the event.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 the green and black insulation came off the tip and fell into the abdomen when doing surgery.The surgeon removed the pieces laparoscopically from the patient's abdomen.Kept the tip and cleaned it.Do not have the original package.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/23/2021.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 the coating and insulation damaged, and not detached as the customer reported.The device was tested for continuity and worked as expected.It should be noted that product failure is multifactorial.It is possible the improper handling of the device could be caused damage to the coating and insulation.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.E4: no.

• Brand Name: LAP MEGATIP ONLY L-WIRE
• Common Device Name: LAPAROSCOPIC MEGATIP ONLY L-WIRE
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 11107753
• Report Number: 1721194-2021-00073
• Device Sequence Number: 4042135
• Product Code: GEI
• UDI-Device Identifier: 10614559101056
• UDI-Public: 10614559101056
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 0600
• Device Catalogue Number: 0600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1