MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 12/14FR X 54 CM 5/BX; URETERAL CATHETER

Model Number	61254BX
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported to olympus, during a retrograde intrarenal surgery (rirs) to remove the kidney stone, the subject device broke during first insertion into the ureter.The urologist reported resistance was felt, stopped actions, and identified the access sheath broke.The device fragments were removed with an unknown instrument easily from the bladder.The surgeon confirmed the pieces were completed removed with a cystoscopy.The was a delay of 'a few minutes' while the surgeon was removing the device fragments.The patient was under general anesthesia and a similar device was used to completed the intended procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 subject device was not returned for evaluation, the review of the images provided show that the white inner sheath broke at the distal end.One image shows the distal tip being broken into multiple fragments.This confirms the claim of the subject device being broken.The multiple fragment photo is likely the fragments that had to be removed from the ureter.However, the cause of this damage was unable to be determined.This supplemental report includes information added to g2.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 12/14FR X 54 CM 5/BX
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC.; todd.brill@olympus.com; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15580652
• Report Number: 3005975494-2022-00050
• Device Sequence Number: 5978587
• Product Code: KNY
• UDI-Device Identifier: 00821925035423
• UDI-Public: 00821925035423
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 61254BX
• Device Lot Number: 09M1700152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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: Other; Required Intervention
• Patient Sex: Unknown