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

Model Number	61254BX
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that the tip of the uropass sheath was damaged as the surgeon was pulling it out during a therapeutic cystoscopy, flexible ureteroscopy, and laser stone fragmentation.The broken pieces were retrieved using a grasper.The procedure was completed after a 5-minute delay.The device was inspected prior to use.There was no further harm or user injury reported due to the event.
Additional Manufacturer Narrative
The device was discarded and was not returned to olympus.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the customer as reflected on b5.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Additional information was received from the customer.The device broke off in the patient's bladder.There were no anatomical challenges or procedural difficulties observed.There was no allegation against the olympus ureteroscope that was used concomitantly.The patient had been discharged.
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 5 years since the subject device was manufactured.Based on the results of the investigation, the photo of the device confirmed that the tip was broken into fragments.However, the root cause could not be determined.This supplemental report includes information added to d8 and h4.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.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16718798
• Report Number: 3003790304-2023-00151
• Device Sequence Number: 7172089
• Product Code: KNY
• UDI-Device Identifier: 00821925035423
• UDI-Public: 00821925035423
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2023

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: 61254BX
• Device Lot Number: 09D1800005
• Was Device Available for Evaluation?: No
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 06/07/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/12/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2018
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS URETEROSCOPE - UNKNOWN MODEL/SERIAL NUMBER.; URETEROSCOPE (UNKNOWN MODEL/SERIAL NUMBER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown