MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SMOKE EVACUATOR RF SENSOR; MEGADYNE¿ RF SENSOR

Model Number	2255J
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
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.No lot number was provided therefore a device history could not be done.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.
Event or Problem Description
It was reported that during an unknown procedure when testing it was found that the rf sensor causes the unit to run continuously.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/2/2023.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 2255j was returned with no apparent damage.The sensor was connected to a generator and intermittent activation was found.No continuous activation was noted during the analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications although no conclusion could be reached on the cause of the reported event.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.Lot: 002140; device history review: null.
Additional Manufacturer Narrative
Pc-(b)(4).

• Brand Name: SMOKE EVACUATOR RF SENSOR
• Common Device Name: MEGADYNE¿ RF SENSOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16282839
• Report Number: 1721194-2023-00033
• Device Sequence Number: 17398228
• Product Code: FYD
• UDI-Device Identifier: 10614559104644
• UDI-Public: 10614559104644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2023

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 Model Number: 2255J
• Device Catalogue Number: 2255J
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 02/08/2023; 02/23/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/23/2023; 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown