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

Model Number 2255J

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

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 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.

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.

Manufacturer Narrative

Pc-(b)(4).

• Brand Name: SMOKE EVACUATOR RF SENSOR
• Type of Device: 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
• MDR Text Key: 308728825
• Report Number: 1721194-2023-00033
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104644
• UDI-Public: 10614559104644
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 02/08/2023; 02/23/2023
• Supplement Dates FDA Received: 02/23/2023; 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1