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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has not been returned.Per report, it was discarded.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus that during therapeutic ureteroscopy, this ureteral catheter tip broke off in patient.The surgeon was able to retrieve all parts from the patient.The procedure was prolonged with an unknown amount of time.The intended procedure was completed with intervention procedure.The device was inspected prior to use.The customer confirmed they knew the stock was expired but decided to use it anyway.There were no reports of further patient or user harm associated with this event.
Event or Problem Description
The customer confirmed that it took a while for the surgeon to retrieve the broken parts of the ureteral access sheath.The user tried different graspers and baskets to retrieve it.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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, it is likely the phenomenon occurred due to the device was used past its expiration date which could be a contributing factor to the device's failure.However, the root cause of the phenomenon could not be determined.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: 17100946
• Report Number: 3011050570-2023-00064
• Device Sequence Number: 7690807
• Product Code: KNY
• UDI-Device Identifier: 00821925035317
• UDI-Public: 00821925035317
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 61024BX
• Device Lot Number: 09D1800206
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BASKETS UNKNOWN MANUFACTURE; GRASPERS UNKNOWN MANUFACTURE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown