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

Model Number	61146BX
Medical Device Problem Codes	Material Frayed (1262); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigations.
Event or Problem Description
As reported, the user were using the device during a stone manipulation procedure.When the device was put over the guide wire and then put into the patient the user noticed an issue.The user noticed that the very tip of the product, the white piece, had frayed and fell off into the patient.The piece that fell off was retrieved from the patient with a flexible grasper with no reported adverse event to the patient.The intended procedure was completed with another similar device.There is no patient harm or injury associated on this reported event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The device was returned for inspection.The device was not returned in the original packaging.The device was inspected.The tip was confirmed to be damaged.The dilator tip had broken off.This is consistent with what the customer reported.The tip fragments that broke off were not returned.The dilator had dried blood left on it and this indicates that the device was used.The rest of the device was inspected for any other damage and there were no other abnormalities other than the broken tip.A dhr (device history record ) review was conducted and both dilator lots used in production for this device passed inspection and no abnormalities were noted.An investigation was completed by the oem (original equipment manufacturer) and 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.

• 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: 12484542
• Report Number: 3003790304-2021-00143
• Device Sequence Number: 17077897
• Product Code: KNY
• UDI-Device Identifier: 00821925035379
• UDI-Public: 00821925035379
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/05/2021

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 Expiration Date: 02/21/2023
• Device Model Number: 61146BX
• Device Lot Number: 09B1800256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• 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: 08/27/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/07/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLEXIBLE GRASPER, GUIDEWIRE
• Patient Sex: Unknown