MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 11/13FR X 38 CM 5/BX

Model Number	61138BX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation as the user disposed the device however photos of the defective devices were provided for evaluation.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly following investigations.
Event or Problem Description
During a therapeutic ureteroscopy procedure the user attempted 3 different access sheaths and each time, the end tip of the inner introducer crumbled.For the two sheaths the issue was found before it was inserted/used on the patient.The parts fell inside the patients¿ kidney when the third sheath was used.The device was visually inspected prior to being inserted and the device appeared to be intact when it was inserted.Under the endoscopic image the parts that fell were removed using a cook basket with model number unknown.The intended procedure was completed using another sheaths with model no.61146bx, lot no.09l1900159.There was no patient harm or injury reported due to the event.There was no user injury reported.This report is related to reports patient identifier (b)(6) and (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The subject devices were not returned to olympus for evaluation.Picture of the broken devices was provided by the customer.The picture shows that each device had a dilator tip broken off.A root cause of the damage was unable to be determined as the devices were not returned.The likely causes could be manufacturing error, shipping damage or user error.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.An investigation was completed by the oem 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 11/13FR X 38 CM 5/BX
• Common Device Name: UROPASS
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• MDR Report Key: 11670708
• Report Number: 3003790304-2021-00068
• Device Sequence Number: 19580099
• Product Code: KNY
• UDI-Device Identifier: 00821925035362
• UDI-Public: 00821925035362
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 61138BX
• Device Lot Number: 09F1600052
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1