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

Model Number MESE1

Device Problems Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993); Ventilation Problem in Device Environment (3027)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure the flow rate is out of spec.The unit was too sensitive so when the autoactivation function came on when it is not supposed to, and deflated the pneumoperitoneum.

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2023.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.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 received: there were no patient injuries reported this time.They found that the flow rate is out of spec during testing.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.

Manufacturer Narrative

(b)(4).Date sent: 3/10/2023.Device analysis: unit was inspected prior to testing and found set to level 3 current sensitivity.Flow test and passive activation performed for troubleshooting and tests passed.Passive activation was performed using provided power cord using 240 vac bench power.(b)(4) was not confirmed.An unexpected noise was heard during the investigation and the unit was found to have carbon filter particulate in the system; this makes the unit unrepairable due to risk of biohazard to the service technicians.Particulate was noted on the decontamination and service woa.There was no impact to the flow or activation test as a result of the carbon particulate found.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.Additional information was requested, and the following was obtained: 1.Was the mese plugged in with the connect cable, rf sensor, or both? the surgeon was using an olympus thunderbeat energy device at the time.The smoke evac connect cable was not connected to the olympus generator at the time.The rf sensor was also not attached to the thunderbeat either.2.What generator was used? a medtronic ft10 esu was used and connected via connect cable to the smoke evac.3.Was the sensitivity level adjusted? all smoke evacs had their sensitivity setting dropped by one bar as a few were being triggered by the grid power intermittently.4.Did the biomed test the activation using an open circuit or closed circuit? this i do not know and will have to ask did the biomed test the activation using an open circuit or closed circuit? at the time we had the set up with no circuit given the lack of consumables and other pieces.1.Who packed the shipment? was it the customer site or jnj representative? the customer 2.Was the device used in surgery between the (b)(4)? the unit was removed from use when the incident occurred and has never been used since.

Manufacturer Narrative

(b)(4).Date sent: 2/23/2023.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: was the mese plugged in with the connect cable, rf sensor, or both? what generator was used? was the sensitivity level adjusted? did the biomed test the activation using an open circuit or closed circuit?.

• 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: 16283528
• MDR Text Key: 308844107
• Report Number: 1721194-2023-00038
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MESE1
• Device Catalogue Number: MESE1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1