MAUDE Adverse Event Report: GYRUS ACMI, INC UROPASS AS 11/13FR X 46 CM 5/BX

Model Number	61146BX
Medical Device Problem Codes	Structural Problem (2506); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer provided photos of the subject device for evaluation.The subject device is being shipped from (b)(6) to united states legal manufacturer for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, the user found the shape of the dilator tip end abnormal, it has straight section however, the subject device has a little diagonal cross section.As the user felt resistance when inserting the uropass on the procedure, it took it out from the patient body and checked this abnormality.The issue found during a therapeutic rirs (retrograde intrarenal surgery) procedure.The subject device was not used on the procedure.The intended procedure was completed using the same set of equipment with no injury or harm to the patient.There was no user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on device return investigation and sbc (service business center) evaluation.The customer reported that tip of a uropass dilator was abnormal.The device was then returned to olympus for evaluation.The device was returned in a plastic bag.The device was not returned with any of the original packaging, the device lot was unable to be determined.The device was curved when examined, this was likely caused by the small bag that the device was returned in.The device was removed and inspected for damage and use.The inner and outer sheaths had some unknown residue on them.The inner sheath tip was examined for the abnormalities and it was confirmed the sheath tip was not smooth.The tip appeared to have been broken off slightly giving it an abnormal finish.There were no fragments of the tip noted by the customer or returned to olympus.The rest of the device was inspected for damaged and there were no other abnormalities discovered other than the tip.A dhr (device history record) review was unable to be performed as the lot number was not available.The oem (original equipment manufacturer ) was unable to provide any investigation report due the lot number was unknown.Olympus will continue to monitor the field performance of this device.

• Brand Name: UROPASS AS 11/13FR X 46 CM 5/BX
• Common Device Name: UROPASS
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana ave n; brooklyn park MN 55445
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12509457
• Report Number: 3003790304-2021-00144
• Device Sequence Number: 4094655
• Product Code: KNY
• UDI-Device Identifier: 00821925035379
• UDI-Public: 00821925035379
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: 61146BX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• 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: 08/31/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 12/09/2021
• 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
• Patient Sex: Prefer Not To Disclose