MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 10/12FR X 24 CM 5/BX; ACCESSORIES, CATHETER, G-U

Model Number	61024BX
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to access the ureter, the surgeon had difficulty inserting the sheath.When the sheath was taken out of the patient, there was a crack noted near the tip and the tip subsequently broke when placed on the operating table.The procedure was completed with a similar device.There was an unspecified delay; however, there were no reports of patient harm.
Additional Manufacturer Narrative
To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: h6 and h11.Corrected field: h6 - type of investigation (code 4111 is not applicable to this event).The device history record was unable to be reviewed since the exact manufacture date is unknown.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned to olympus for inspection, therefore the customer's reportable malfunction could not be confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, is likely that the tip broke occurred due to dilator performance impact caused by: aging of the dilators throughout the lifecycle of the product, and ultraviolet (uv) exposure.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 10/12FR X 24 CM 5/BX
• Common Device Name: ACCESSORIES, CATHETER, G-U
• 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: 18861983
• Report Number: 3011050570-2024-00094
• Device Sequence Number: 3338226
• Product Code: KNY
• UDI-Device Identifier: 00821925035317
• UDI-Public: 00821925035317
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 61024BX
• Device Lot Number: 09E21000333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 07/30/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown