MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE ACE BLADE 700M ZIP E; E-Z CLEAN WIRE L-WIRE LAP 45CM

Model Number	0100L
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/6/2020.Batch #unk.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 was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during a laparatomy vaginal hysterectomy, the teflon coating around the electrode exploded.A second like device was tried and it did the same thing.A force triad generator was being used at that time.It is unknown how the procedure was completed and there were no patient consequences reported.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Corrected data: brand name, mfr site.Investigation summary: one of each me725m1e was received with unknown lot numbers.This device was received, but was not on original report.The device was returned without the electrode.During visual inspection, excessive blood and debris was present.The device was functionally tested and found to be performing within specifications.

• Brand Name: MEGADYNE ACE BLADE 700M ZIP E
• Common Device Name: E-Z CLEAN WIRE L-WIRE LAP 45CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9676655
• Report Number: 1721194-2020-00018
• Device Sequence Number: 2704530
• Product Code: GEI
• UDI-Device Identifier: 10614559102640
• UDI-Public: 10614559102640
• Combination Product (Y/N): N
• PMA/510(K) Number: K141587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 0100L
• Device Catalogue Number: ME725M1E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1