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

Model Number 61254BX

Device Problem Break (1069)

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

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

The device has been returned to olympus, 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 Description

The customer reported to olympus that during therapeutic cystoscopy, ureteroscopy and laser stone, the tip of the uropass sheath broke inside the patient.The bits were fished out of the bladder.The procedure was delayed for five minutes and completed with a different size access sheath.The device was an expired item.The device was inspected before use but did not notice it was expired until they had to "riskman" the incident.There were no reports of patient or user harm associated with this event.

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 customer¿s reported complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 6 years since the subject device was manufactured.Based on the results of the investigation, the dilator was observed to be very brittle and was broken even with careful handling.However, it was determined that the device was expired when used by the customer.This supplemental report includes a correction to g2 and h3.Also, additional information has been added to h4.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

The initial medwatch incorrectly reported the site registration number.The site registration number is 3011050570.

• Brand Name: UROPASS AS 12/14FR X 54 CM 5/BX
• Type of Device: URETERAL CATHETER
• 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: 16828705
• MDR Text Key: 314161210
• Report Number: 3005975494-2023-00081
• Device Sequence Number: 1
• Product Code: KNY
• UDI-Device Identifier: 00821925035423
• UDI-Public: 00821925035423
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61254BX
• Device Lot Number: 09F1700105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2017
• 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
• Patient Outcome(s): Required Intervention