MAUDE Adverse Event Report: GYRUS ACMI, INC UROPASS AS 12/14FR X 38 CM 5/BX; UROLOGIC CATHETERS AND ACCESSORIES

Model Number	61238BX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.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 a laser ureteroscopic stone removal procedure using a uropass access sheath, the sheath tip broke off into the patient.The tip was retrieved and procedure was completed with no further consequences to the patient.Additional details regarding the patient and reported event were requested.The customer was unable to provide the requested information.
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.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 a laser ureteroscopic stone removal procedure using a uropass access sheath, the sheath tip broke off into the patient.The tip was retrieved and procedure was completed with no further consequences to the patient.Additional details regarding the patient and reported event were requested.The customer was unable to provide the requested information.
Additional Manufacturer Narrative
This report is being update to report additional information reported by the customer and investigation findings.Physical evaluation of the returned device: the device was returned with the original packaging.The model and lot number were confirmed to be 61238bx and lot: 09d1700148.The device was received in fragments.The blue outer sheath appears to have no damage.The white inner sheath has been broken multiple times.The very tip was broken off, that fragment was found inside the packaging.The distal tip has some dried blood leftover indicating use.This tip was also broken a few more times up the shaft.The cause of the damage was unable to be determined.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.An investigation was completed by the oem 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.
Event or Problem Description
Additional information provided by the customer: patient demographics and pre-existing conditions are not available.The procedure being performed was a ureteroscopic stone removal with laser.The indication for the procedure is not available.It is unknown if there were any anatomical or procedural challenges that could have contributed to the reported event.It is not known how the device fragment was removed from the patient.There were no adverse effects to the patient as a result of this occurrence.The device is available for return.It is unknown what/if concomitant devices were being used at the time the uropass broke inside the patient.

• Brand Name: UROPASS AS 12/14FR X 38 CM 5/BX
• Common Device Name: UROLOGIC CATHETERS AND ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana ave n; brooklyn park MN 55445
• Manufacturer Contact: kenneth pittman ; 800 west park drive; westborough, MA 01581 ; 9013785969
• MDR Report Key: 13308711
• Report Number: 3003790304-2022-00016
• Device Sequence Number: 4965337
• Product Code: KNY
• UDI-Device Identifier: 00821925035409
• UDI-Public: 00821925035409
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 61238BX
• Device Lot Number: 09D1700148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/23/2021
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNSPECIFIED LASER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown