MAUDE Adverse Event Report: GYRUS ACMI, INC UROPASS AS 10/12FR X 24 CM 5/BX; URETERAL CATHETER

Model Number	61024BX
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during a primary pyeloscopy and laser to right kidney stone using a single use access and an uretero-reno-videoscope, when attempting to remove the scope after the laser of the renal stone had been completed, the physician was unable to withdrawal the scope through the access sheath.Resistance was noted before the top of the scope was able to enter access sheath.The scope became stuck and resulted in a ureteric avulsion.The procedure was aborted, and an urgent percutaneous nephrostomy was performed.The patient was hospitalized for 5 days and was given iv antibiotics, a percutaneous nephrostomy tube and imaging.The patient is currently scheduled to have a nephrectomy.After withdrawal, it was noted there was damage to the access sheath which is believed by the surgical team to be the reason the scope was unable to be withdrawn normally from the ureter.The scrub nurse confirmed scope looked normal and in good condition prior to insertion into the patient ureter.Images of the scope and device used in this procedure were received.The photo of the white tip shows that the dilator tip has been broken off.Case with patient identifier (b)(6) reports the access sheath used in the procedure.Case with patient identifier (b)(6) reports the scope used in the procedure.
Additional Manufacturer Narrative
The device referenced in this report has been received.Partial evaluation completed.The investigation is ongoing.Device evaluation: images of the scope and device used in this procedure were received.The photo of the white tip shows that the dilator tip has been broken off.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional device evaluation findings.Additional device evaluation findings are as follows: there was no notable damage to the sheath; however, there was damage (fracture/break) to the dilator tip.When tested, the scope was able to move smoothly throughout the sheath.Therefore, the customer's claim of the scope getting stuck in the sheath could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, although the dilator tip was broken off, the customer¿s complaint could not be confirmed.Therefore, the root cause could not be determined.This supplemental report includes a correction to b3 and d4 from the initial medwatch.Also, new information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 10/12FR X 24 CM 5/BX
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana ave n; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15722159
• Report Number: 3005975494-2022-00059
• Device Sequence Number: 17943223
• Product Code: KNY
• UDI-Device Identifier: 00821925035317
• UDI-Public: 00821925035317
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2023

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: 61024BX
• Device Lot Number: 09K1800191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 02/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown