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

Catalog Number MESE1

Device Problems Difficult or Delayed Activation (2577); Ventilation Problem in Device Environment (3027); Appropriate Term/Code Not Available (3191)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: (b)(6) 2023 b3: only event year known: 2023 an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete 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.

Event Description

It was reported that during a testing the short plug was not recognized.The mese1 is acting as designed and the device does not need to be returned for service.We set the generators current sensor sensitivity up and that worked.The activation seemed normal.But then it seemed a bit slow with the cut button.They turned it up a notch, it kept on going.They turned it down, it kept on going.They put it back to setting 3, as we started out, and it worked like a charm.Then, the machine started to turn on randomly.So the pencil way plugged in, but laying down on the table, no activations were done, but despite, the mese1 was activated multiple times.¿ ¿they also had a plug/work around instead of a megasoft/return elektro.¿.

Manufacturer Narrative

(b)(4).Date sent: 11/29/2023.Additional information received: the incident took place in the (b)(6) hospital location (b)(6) i believe.The description doesn¿t seem complete though.Nor correct in terms of products used except for the mese1, which is correct.We never specified the 0035l (this is not a pencil with smoke evacuation) and not the megasoft.The service engineer didn¿t specify.In the end, we reset set the sensitivity again with a sticky pad of an unspecified brand, created a full electrical circuit.So reset sensitivity from 3 to four, activated, set back to setting 3.Thereby resetting the machine and since then there were no complaints anymore.The machine is currently actively used.There were no patient consequences.They did discover it during surgery but the electrosurgical effect was good, only the small amount of smoke didn¿t always get evacuated.

• Brand Name: SMOKE EVACUATOR
• Type of Device: MEGADYNE¿ SMOKE EVACUATOR
• 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: 17542111
• MDR Text Key: 321536772
• Report Number: 1721194-2023-00101
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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 Catalogue Number: MESE1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1