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

Model Number 2255J

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/12/2022

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 or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: could you please send a photo of the device no photo is available.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, the black plastic part for cord was detached and the inside exposed.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: SMOKE EVACUATOR RF SENSOR
• Type of Device: MEGADYNE¿ RF SENSOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: orla o'mahony ; 11506 south state street; draper 84020
• MDR Report Key: 14496852
• MDR Text Key: 300039054
• Report Number: 1721194-2022-00039
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104644
• UDI-Public: 10614559104644
• Combination Product (y/n): N
• PMA/PMN Number: K200250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2022

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?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1