MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 12/14FR X 46 CM 5/BX; URETERAL CATHETER

Model Number	61246BX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, this device has not been returned for evaluation.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
An olympus representative reported to olympus on behalf of the customer that during bilateral endoscopic combined intra-renal surgery (ecirs) using this ureteral access sheath, the tip of the access sheath broke while inside the patient.The broken tip has been retrieved.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection inside a plastic bag with none of the original packaging.The device was removed from the bag and inspected.The dilator was inserted into the blue sheath, the tip of the dilator appeared to have been fractured.The tip appeared to have been fragmented.None of the fragments were returned.The dilator was removed from the sheath and it was extremely brittle, towards the tip, the dilator was broken when attempted to be bent slightly.The reportable malfunction was confirmed.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 formal investigation, the root cause was found to be embrittlement and degradation of the dilator polymer due to variable storage methods and environment exposure in health care facilities.As a result, the uropass device shelf life was reduced from 60 months to 30 months in 2019.Given the result of the previous dilator break investigation and given the result of this complaint¿s investigation, particularly the fact that the part in question was expired at the time of the incident, this root cause cannot be confirmed.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 12/14FR X 46 CM 5/BX
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16542516
• Report Number: 3003790304-2023-00119
• Device Sequence Number: 6520881
• Product Code: KNY
• UDI-Device Identifier: 00821925035416
• UDI-Public: 00821925035416
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: 61246BX
• Device Lot Number: 61246BX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2401-2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown