MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 10/12FR X 24 CM 5/BX; ACCESSORIES, CATHETER, G-U

Model Number 61024BX

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

This device has not been returned.Per report, it was discarded.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that during therapeutic ureteroscopy, this ureteral catheter tip broke off in patient.The surgeon was able to retrieve all parts from the patient.The procedure was prolonged with an unknown amount of time.The intended procedure was completed with intervention procedure.The device was inspected prior to use.The customer confirmed they knew the stock was expired but decided to use it anyway.There were no reports of further patient or user harm associated with this event.

Event Description

The customer confirmed that it took a while for the surgeon to retrieve the broken parts of the ureteral access sheath.The user tried different graspers and baskets to retrieve it.

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, it is likely the phenomenon occurred due to the device was used past its expiration date which could be a contributing factor to the device's failure.However, the root cause of the phenomenon could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 10/12FR X 24 CM 5/BX
• Type of Device: ACCESSORIES, CATHETER, G-U
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17100946
• MDR Text Key: 316949363
• Report Number: 3011050570-2023-00064
• Device Sequence Number: 1
• Product Code: KNY
• UDI-Device Identifier: 00821925035317
• UDI-Public: 00821925035317
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K051593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61024BX
• Device Lot Number: 09D1800206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BASKETS UNKNOWN MANUFACTURE; GRASPERS UNKNOWN MANUFACTURE
• Patient Outcome(s): Required Intervention