MAUDE Adverse Event Report: GYRUS ACMI, INC. DISPOSA-FILTER 10/PKG; SURGICAL SUCTION SYSTEM COLLECTION CONTAINER, SINGLE-USE

Model Number	54298
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the disposa-filter 10/pkg had an out of box failure with 1 piece, from a box of 10, was found broken.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the initial medwatch report (mdr).The initial mdr was inadvertently submitted as a reportable malfunction as there was no reportable malfunction related to the subject device captured in this complaint.Per the legal manufacturer, this issue of a broken disposa filter is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: DISPOSA-FILTER 10/PKG
• Common Device Name: SURGICAL SUCTION SYSTEM COLLECTION CONTAINER, SINGLE-USE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18592734
• Report Number: 3011050570-2024-00027
• Device Sequence Number: 6810979
• Product Code: HHK
• UDI-Device Identifier: 00821925037663
• UDI-Public: 00821925037663
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: 54298
• Device Lot Number: 2464341
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 01/27/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown