MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 11/13FR X 24 CM 5/BX

Model Number	61124BX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during transurethral lithotomy procedure, the root of the sheath broke about 20 minutes after the start of use.The coil of the sheath did not came out.The device was replaced with similar device and the intended procedure was completed with no patient harm or injury reported due to the event.No user injury was reported.
Additional Manufacturer Narrative
The subject device was not returned for evaluation, however, photo of the subject device was provided for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.

• Brand Name: UROPASS AS 11/13FR X 24 CM 5/BX
• Common Device Name: UROPASS
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12789924
• Report Number: 8010047-2021-14420
• Device Sequence Number: 3840407
• Product Code: KNY
• UDI-Device Identifier: 00821925035454
• UDI-Public: 00821925035454
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 61124BX
• Device Lot Number: OXH
• Was Device Available for Evaluation?: No
• 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: 10/21/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: URF-V3 SCOPE
• Patient Sex: Female