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

Catalog Number MESE1

Device Problems Difficult or Delayed Activation (2577); Noise, Audible (3273)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that during the comprehensive inspection we connected it to mega power1000 and confirmed that it did not stop after it was connected.We have confirmed that the pump is making an abnormal noise.There was no adverse consequence to the patient.The customer does not want to provide additional information.

Manufacturer Narrative

(b)(4).Date sent: 1/11/2024 b3: only event year known: 2023 per service manual operational and diagnostic analysis confirmed the continuous activation and the noise issue.The scroll pump was replaced to address the noise issue and the pcb contact board assembly was replaced to address the continuous activation.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The repair and testing of the unit was completed.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.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.

• 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 ; PR ; 3035526892
• MDR Report Key: 18492131
• MDR Text Key: 333207782
• Report Number: 1721194-2024-00004
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1