MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 10/12FR X 54 CM 5/BX; UROPASS URETERAL ACCESS SHEATH

Model Number	61054BX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	02/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has been returned for evaluation.However, an evaluation has not been completed at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus that during a retrograde intrarenal surgery, three uropass ureteral access sheath broke at the distal end of the dilator inside the patient.The procedure was completed by replacing with another sheath however it was shorter.The fragments that fell into the patient have been removed but caused extension of the procedure for one and a half hours.The patient was under general anesthesia.The anesthetist reported to the physician that the patient had an early pulmonary edema and was given a diuretic which seemed to have not made the problem more serious.It was thought to be a consequence of patient being under general anesthesia for a time longer than expected.There were no reports of further patient or user harm associated with this event.(b)(6) 1 of 3 uropass ureteral access sheath.(b)(6) 2 of 3 uropass ureteral access sheath.(b)(6) 3 of 3 uropass ureteral access sheath.
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 reported defect was confirmed.The evaluation results are as follows: all three dilator tips were broken.One dilator had a clean break about 7.5 cm from the very tip.Another dilator had a fragmented break with the tapered dilator tip.The last dilator appears to have a clean break closer to the tapered end of the device.Although the dilator damage was confirmed, none of the returned devices appeared to have any damage to the blue sheath or to the proximal end of the dilator.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, although the dilator damage was confirmed, the root cause of the reported damage is unable to be determined.This supplemental report includes information added h4.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 10/12FR X 54 CM 5/BX
• Common Device Name: UROPASS URETERAL ACCESS SHEATH
• 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: 16492576
• Report Number: 3003790304-2023-00101
• Device Sequence Number: 6374528
• Product Code: KNY
• UDI-Device Identifier: 00821925035348
• UDI-Public: 00821925035348
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 61054BX
• Device Lot Number: 09D1800005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• 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: 02/05/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown