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

Model Number 61254BX

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 02/14/2023

Event Type  Injury  

Event 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.

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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 313115283
• Report Number: 3003790304-2023-00151
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• 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: 09D1800005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OLYMPUS URETEROSCOPE - UNKNOWN MODEL/SERIAL NUMBER.; URETEROSCOPE (UNKNOWN MODEL/SERIAL NUMBER).
• Patient Outcome(s): Required Intervention