MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 13/15FR X 24 CM 5/BX; ACCESSORIES, CATHETER, G-U

Model Number	61324BX
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The olympus sales representative reported on behalf of the customer that the during therapeutic uretherscopy, the tip of uropass as 13/15fr x 24 cm 5/bx broke and part fell inside the patient and per physician the tip is believed to be inside the patient.No tests have been performed to verify the status of the tip of device.It was stated that the procedure was completed and no patient harm occurred.Details of the patient's current condition was requested but not available at the time of the report.
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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, the customer used the device that was manufactured on 10dec2015.This device had a 5 year shelf life and expired on 10dec2020.The reported date of the event was 21jun2023.This device was considered expired when it was used.It is likely that the suggested event occurred based on the customer used an expired device.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 13/15FR 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: 17342158
• Report Number: 3011050570-2023-00085
• Device Sequence Number: 6903464
• Product Code: KNY
• UDI-Device Identifier: 00821925035430
• UDI-Public: 00821925035430
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 61324BX
• Device Lot Number: 09J1500009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown