MAUDE Adverse Event Report: GYRUS ACMI, INC. UNIVERSAL STOPCOCK, LUER LOCK; LARYNGOSCOPE, RIGID

Model Number	75U
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection, that the universal stopcock had multiple pieces of foreign material on the white plastic of the handle assembly.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Section h11 is being corrected with information that was inadvertently omitted from the supplemental report.The sales representative reported that there were shavings in the stop-cock.The investigation concluded that the presence of shavings inside of the device was a result of an approved rework process that was integrated into the assembly process.The model number is 75u and lot ah.All components, including the handle, luer lock, and the nut driver, were found intact.No physical damage on the external surfaces was observed.Multiple pieces of foreign material were on the white plastic of the handle assembly, a significant shaving piece was found hanging from the white plastic at the sealing ring of the handle assembly, and rust was observed on the nut driver threads and internal surface of the stopcock body.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation the root cause could not be identified; however it is likely that the presence of shavings inside the returned device following led to the malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: UNIVERSAL STOPCOCK, LUER LOCK
• Common Device Name: LARYNGOSCOPE, RIGID
• 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: 19168894
• Report Number: 3011050570-2024-00143
• Device Sequence Number: 20669931
• Product Code: CCW
• UDI-Device Identifier: 00821925007321
• UDI-Public: 00821925007321
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K883819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2024

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: Other
• Device Model Number: 75U
• Device Lot Number: AH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/13/2024; 06/13/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/24/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown