MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 10/12FR X 46 CM 5/BX; ACCESS SHEATH

Model Number	61046BX
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is scheduled to be returned to olympus, but has not yet arrived.If additional information becomes available, a supplemental report will be filed.
Event or Problem Description
As reported, during the removal of a stone by the uropass device, the material was removed from the uropass and fell into the patient.All the pieces of the stone were successfully removed from the patient.There was no patient harm reported as a result of this event.
Event or Problem Description
Additional information was received on 10feb2021 confirming there were no injuries to the patient.Additionally, the plastic particles that fell into the patient were removed using forceps, which caused approximately a 15 minute delay in the procedure.The patient's overall stay in the facility was not extended.The initial reporter confirmed that the device was inspected prior to use.There was no bleeding, abnormality, or otherwise danger to the patient.The procedure being performed as an unspecified therapeutic procedure.There were no other devices involved and the procedure was successfully completed with a similar device.Patient demographics remain unavailable.
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A device evaluation and a review of the device history record (dhr) was conducted during this investigation.The device was returned wrapped in a plastic bag, indicating it was a contaminated device.The label for the device had been removed from the original packaging and was included.The device was examined, and it was noted that only the sheathing of the device was provided.The dilator of the device was not returned.There was no notable damage on the sheath.Investigation was unable to confirm the user¿s report since no damage was discovered on the sheath and the dilator was not provided.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.From the results of the investigation, 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.
Additional Manufacturer Narrative
Upon further review, it was determined that this event is a serious injury.Corrections made to b1, b2, h1 and h6.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to the initial with information inadvertently left out e1-email address, e2, e3, g2, and h6 (type of investigation and medical device problem code).Additionally, to provide a correction to the initial h6- investigation conclusion.

• Brand Name: UROPASS AS 10/12FR X 46 CM 5/BX
• Common Device Name: ACCESS SHEATH
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane n, ste 160; plymouth MN 55447
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 11224348
• Report Number: 3003790304-2021-00019
• Device Sequence Number: 3859674
• Product Code: KNY
• UDI-Device Identifier: 00821925035331
• UDI-Public: 00821925035331
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 61046BX
• Device Lot Number: 09L1900002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/10/2021; 04/16/2021; 08/14/2023; 03/06/2024; 03/21/2024
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/08/2021; 04/23/2021; 08/14/2023; 03/18/2024; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2401-2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown