MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 12/14FR X 24 CM 5/BX; UROPASS URETERAL ACCESS SHEATH

Model Number	61224BX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received to date.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
An olympus sales representative reported that the uropass access sheath broke off during ureteroscopy.The inside of the sheath was very brittle and almost dried out.A scan was performed and no fragments could be seen in the patient.Therefore, the doctor concluded that the broken piece did not remain in the body.There was no patient injury or adverse outcome to the patient reported.
Additional Manufacturer Narrative
The device was not returned for evaluation and there were no pictures of the device to confirm the brittleness of the device.A device history record review was performed on the device lot and no abnormalities were noted.An investigation was completed by the original equipment manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be environmental exposure of the device, which resulted in degradation and embrittlement of the polymer.Olympus will continue to monitor the field performance of this device.

• Brand Name: UROPASS AS 12/14FR X 24 CM 5/BX
• Common Device Name: UROPASS URETERAL ACCESS SHEATH
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis ln n, suite 160; plymouth MN 55447
• MDR Report Key: 12045296
• Report Number: 8010047-2021-07851
• Device Sequence Number: 3857557
• Product Code: KNY
• UDI-Device Identifier: 00821925035393
• UDI-Public: 00821925035393
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K051593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 61224BX
• Device Lot Number: 09F1600053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1