MAUDE Adverse Event Report: GYRUS ACMI, INC UROPASS AS 12/14FR X 38 CM 5/BX; ACCESSORIES, CATHETER, G-U

Model Number	61238BX
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report will be evaluated via picture.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus, the first insertion of the urpoass 12/14fr, 38cm was successful.The flexible urf goes via the uropass to successfully reach the renal stone and conduct stone laser lithotripsy.However; urologists found it difficult to in re-insert the urpoass into the patient during the middle of a therapeutic a retrograde intrarenal surgery (rirs) procedure.The inner sheath of the uropass had broken into pieces.The procedure was delayed for approximately 15 minutes as the physician retrieved the pieces from the patient¿s ureter and bladder, using grasping forceps.The patient was under general anesthesia at the time of the event.The procedure was completed using another 61238bx uropass.According to the customer, an x-ray is routinely used for this type of procedure.There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: the picture shows that the white inner sheath was fractured into multiple pieces.All the fragments appear to have been retrieved.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, the white inner sheath was fractured into multiple pieces confirming the reported damage.However, the root cause of the issue was unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 12/14FR X 38 CM 5/BX
• Common Device Name: ACCESSORIES, CATHETER, G-U
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana ave n; brooklyn park MN 55445
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 14526934
• Report Number: 3003790304-2022-00087
• Device Sequence Number: 12309724
• Product Code: KNY
• UDI-Device Identifier: 00821925035409
• UDI-Public: 00821925035409
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 61238BX
• Device Lot Number: 09E1700146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2017
• 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 URF SCOPE
• Patient Sex: Unknown