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

Model Number	61224BX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation.Customer disposed of the device, and does not have the lot number.Photo of the device was provided instead.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, during a ureteroscopy procedure, the device broke inside of patient.The device fractured in the middle and in another area.The device was able to be retrieved and the intended procedure was completed.There was no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
The subject device was not returned for evaluation.Customer disposed of the device, and does not have the lot number.Photo of the device was provided instead.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, during a ureteroscopy procedure, the device broke inside of patient.The device fractured in the middle and in another area.The device was able to be retrieved and the intended procedure was completed.There was no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 the investigation, the photo of the device showed that the blue outer sheath broke in two places.The sheath broke towards the proximal end by the funnel shaped part of the sheath.The sheath also broke further down towards the distal end.The white inner sheathing was not shown in any images provided and the device was not returned for evaluation.Based on the context of the complaint it is unknown if the inner sheath broke as well or just the blue outer.Testing was completed on the lot but unable to replicate the issue.The specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 12/14FR X 24 CM 5/BX
• Common Device Name: UROPASS
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis ln n, suite 160; plymouth MN 55447
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12965245
• Report Number: 3003790304-2021-00185
• Device Sequence Number: 4573346
• Product Code: KNY
• UDI-Device Identifier: 00821925035393
• UDI-Public: 00821925035393
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 09H1800012
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown