MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE ACE BLADE 700M ZIP E

Model Number	ME725M1E
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	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported pre-op the the breast mass excision procedure that when opening the product onto the back table, the black sleeve that makes the blade, a modified tip, came off.This happened prior to the case we opened a new device.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/11/2023.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Pencil and electrode were received for analysis, upon visual analysis of the returned sample determined that the me725m1e electrode was returned with the black insulation detached and returned.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.A manufacturing record evaluation was performed for the finished device lot 1910073, and no non-conformances were identified.

• Brand Name: MEGADYNE ACE BLADE 700M ZIP E
• Common Device Name: MEGADYNE ACE BLADE 700M ZIP
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16554303
• Report Number: 1721194-2023-00053
• Device Sequence Number: 4948189
• Product Code: GEI
• UDI-Device Identifier: 10614559105672
• UDI-Public: 10614559105672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: 09/30/2023
• Device Model Number: ME725M1E
• Device Catalogue Number: ME725M1E
• Device Lot Number: 1910073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown