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

Model Number MESE1

Device Problems Difficult or Delayed Activation (2577); Appropriate Term/Code Not Available (3191)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event year known: 2022.Serial 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.Additional information was requested, and the following was obtained: was the rf sensor being used? (ans.) yes.Was the connect cable being used? (ans.) there is no imformation about this.What is the energy device that was attached to the unit? (ans.) there is no information about this.Does the until continue to activate when nothing is being done to the system.(ans.) i am not sure what this question is asking.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 device was not linked to activation and continues to aspirate or does not respond to activation.There was no adverse consequence to the patient.The customer does not want to provide additional information.

Manufacturer Narrative

(b)(4).Date sent: 5/19/2022.Investigation summary: per service manual operational and diagnostic analysis confirmed that the unit does not link to activation and continues to aspirate (or does not respond to activation).The foot control wire was identified in the investigation to address the issue.The repair was not approved and the unit was returned unrepaired.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.

Manufacturer Narrative

(b)(4).Date sent: 7/6/2022.Additional information provided: it was reported by the sales rep that, during an unknown procedure, the device did not synchronize with the energy device.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Date sent: 7/22/2022.Additional information provided: the product was in the custom kit, the custom kit code is ¿eek1017¿ and this kit is assembled in japan for japanese customer.

Manufacturer Narrative

(b)(4).Date sent: 8/18/2022.Additional information received: this is an out of box issue.

Manufacturer Narrative

(b)(4).Date sent: 9/22/2022.Investigation summary: per service manual operational and diagnostic analysis confirmed that the unit does not link to activation and continues to aspirate (or does not respond to activation).The foot control wire was identified in the investigation to address the issue.The repair was not approved and the unit was returned unrepaired.

• Brand Name: SMOKE EVACUATOR
• Type of Device: MEGADYNE¿ SMOKE EVACUATOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 84020
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kara ditty-bovard ; 11506 south state street; draper, UT 84020 ; 6107428552
• MDR Report Key: 13801740
• MDR Text Key: 289112902
• Report Number: 1721194-2022-00014
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/22/2022

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: MESE1
• Device Catalogue Number: MESE1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 05/17/2022; 07/05/2022; 07/07/2022; 08/04/2022; 09/08/2022
• Supplement Dates FDA Received: 05/20/2022; 07/06/2022; 07/22/2022; 08/18/2022; 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1