MAUDE Adverse Event Report: GYRUS ACMI, INC UROPASS AS 11/13FR X 38 CM 5/BX; ACCESSORIES, CATHETER, G-U

Model Number	61138BX
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject was returned and was received at olympus service business center korea (sbc-okr) on october 26, 2022 and is being shipped to original equipment manufacturer (oem) for evaluation.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported, at preparation for use, the user tried to use the product after opening , however, it was stated that it was difficult to use due to the product was bent significantly compared to the normal product.According to the report, it was stated that the product itself too stiff and curved, making it difficult to use for patients.The device was replaced.The intended therapeutic rirs (retrograde intrarenal surgery) procedure was completed using a similar device.No patient harm , no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the device evaluation.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.The device was returned in the original tyvek packaging and the device was intact with no visual defects.The device has an insignificant arch that remains within standard limits.The device can easily be bent and no additional resistance or stiffness was felt while manipulating the device.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 root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 11/13FR X 38 CM 5/BX
• Common Device Name: ACCESSORIES, CATHETER, G-U
• Manufacturer (Section D): GYRUS ACMI, INC; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15807169
• Report Number: 3003790304-2022-00298
• Device Sequence Number: 17579451
• Product Code: KNY
• UDI-Device Identifier: 00821925035362
• UDI-Public: 00821925035362
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: 09L2100130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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
• Patient Sex: Unknown