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
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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 and inside the stopcock body.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the foreign material was found to be three pieces of debris with two white colored and one yellow-brown colored.Further inspection also found pieces of white plastic and rust in the device.However, the root cause could not be identified.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Although the device history record was unable to be reviewed for this device, the model number# was verified to be 75u and the lot# was bc as shown on the physical device.The root cause of the event was determined to be because of the presence of shavings inside the returned device which was a result of rework integrated into the assembly process.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: 19160664
• Report Number: 3011050570-2024-00141
• Device Sequence Number: 7330413
• 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): 06/19/2024

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: Other
• Device Model Number: 75U
• Device Lot Number: BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/14/2024; 06/19/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/18/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2019
• 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