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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative, on behalf of the customer, reported that the uropass broke in the patient during an unspecified urinary therapeutic procedure.The tip of the dilator broke off inside the ureter when the access sheath was initially inserted into the ureter.The surgeon didn¿t know that the tip broke off until they lasered the stone.The surgeon accidentally lasered the broken tip of the access sheath and that¿s when they discovered the tip had broken off.A flexible ureteroscope was inside the sheath when the broken tip was discovered.Additionally, a guidewire was inside the sheath when the tip broke.No error messages showed up, as the device is disposable.The procedure was prolonged (by an unknown amount of time) because they had to open a stone basket to pull out the tip of the sheath.The tip was cut with the laser fiber so it could be safely removed from the patient without damaging the ureter.The procedural outcome was unknown.The patient condition was not impacted, and no additional intervention was needed.
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.
Event or Problem Description
Other related patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a specific root cause of the uropass sheath broke inside a patient during use could not be identified with the information received.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.; 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: 17643120
• Report Number: 3003790304-2023-00337
• Device Sequence Number: 5590591
• Product Code: KNY
• UDI-Device Identifier: 00821925035409
• UDI-Public: 00821925035409
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: 61238BX
• Device Lot Number: 09J1800101
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2401-2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLEXIBLE URETEROSCOPE (URF-P6R)-LOT UNKNOWN; UNKNOWN GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown