MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 12/14FR X 38 CM 5/BX; URETERAL ACCESS SHEATH

Model Number	61238BX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported, the olympus uropass's tip separated while in use.According to the initial reporter, the surgeon attempted to retrieve all the broken pieces.The scrub nurse did managed to retrieve some segments.However, after going to the bathroom, the patient noted some 'white remnants' that were possibly from the ureteral access sheath.There was no patient harm or consequence reported as a result of this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the original equipment manufacturer (oem) investigation.Due to the lack of contact information noted in the file per customer's request, no diligence efforts were made.The device was not returned to olympus, thus no physical evaluation of the device done.The customer's complaint was not able to be confirmed.The oem performed an investigation.A dhr review was conducted and the dilator lot passed inspection with no abnormalities noted.It is likely the cause of the event is environmentally related exposure of the device in the health care facility which resulted in degradation and embrittlement of the dilator polymer.The oem believes there was no manufacturing, material, or process related cause for this failure mode that would be considered within oem control.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.Based on the legal manufacturer¿s investigation, ¿the failure mode of tip breakage was reviewed by the research and development material science group, and they determined that the failure mode to be linked to non-uniform blending of the radiopaque additive to the base material, which creates a localized compromising effect for buckle strength.The non-uniform blending is a random occurrence across all french size and length offerings nor is it lot specific.¿ the investigation has been closed and no further action was taken.Furthermore, the device history record could not be reviewed as it was not made available to olympus by the legal manufacturer.Olympus will continue to monitor the field performance of this device.

• Brand Name: UROPASS AS 12/14FR X 38 CM 5/BX
• Common Device Name: URETERAL ACCESS SHEATH
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis ln n, suite 160; plymouth MN 55447
• MDR Report Key: 11692793
• Report Number: 3003790304-2021-00069
• Device Sequence Number: 3610651
• Product Code: KNY
• UDI-Device Identifier: 00821925035409
• UDI-Public: 00821925035409
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2021

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: 61238BX
• Device Lot Number: 09K1700042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 07/15/2021; 08/11/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 07/20/2021; 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1