MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 13/15FR X 38 CM 5/BX; ACCESSORIES, CATHETER, G-U

Model Number	61338BX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during an x-ray following a transurethral urinary calculus removal procedure using a uropass sheath, a foreign body was found to remain in the urinary tract.A second flexible transurethral ureterolithotripsy (f-tul) was performed and the foreign body was collected.The foreign body was about 10 mm in length, white, and had cracks around 4 mm from the tip.The stump had been torn diagonally.The customer speculates it is the tip of the uropass sheath that may have been broken when the stones were collected using the basket forceps.There were no additional consequences to the patient reported.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation (although it is anticipated).The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer reports during an x-ray following a transurethral urinary calculus removal procedure using a uropass sheath, a foreign body was found to remain in the urinary tract.A second flexible transurethral ureterolithotripsy (f-tul) was performed and the foreign body was collected.The foreign body was about 10 mm in length, white, and had cracks around 4 mm from the tip.The stump had been torn diagonally.The customer speculates it is the tip of the uropass sheath that may have been broken when the stones were collected using the basket forceps.There were no additional consequences to the patient reported.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation (although it is anticipated).The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned for evaluation.When the two foreign objects sent were lined up, the cross sections matched, and it was found that they were originally one.Since the dilator body was not returned, the returned parts were compared with the dilator tip of the same product (61338bx) and it had the same shape as the debris.Since the foreign matter had the same shape as the tip of the dilator, it was considered to be a fragment of the tip of the dilator.Based on the results of the investigation, it is probable that the tip of the dilator was damaged due to the strong addition to the tip of the dilator, and debris was generated.The likely cause of the damage is user mishandling or a manufacturing error.The instructions for use were reviewed and state appropriate inspection steps and warnings to stop using in case resistance is experienced.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 13/15FR X 38 CM 5/BX
• Common Device Name: ACCESSORIES, CATHETER, G-U
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• Manufacturer Contact: kenneth pittman ; 800 west park drive; westborough, MA 01581 ; 9013785969
• MDR Report Key: 13065954
• Report Number: 3003790304-2021-00200
• Device Sequence Number: 5630791
• Product Code: KNY
• UDI-Device Identifier: 00821925035447
• UDI-Public: 00821925035447
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 61338BX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/24/2022
• 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-P6, BASKET FORCEPS (MODEL UNK).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male