MAUDE Adverse Event Report: GYRUS ACMI, INC. SOF-CURL URETERAL STENT 6.0X24; POLYMERIC URETERAL STENT

Model Number 5626024

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

The suspect device referenced in this report has not been returned to olympus.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

The customer reported that the sof-curl ureteral stent 6.0x24 could not be found at its intended place as confirmed through x-ray and that the curls were in the renal pelvis.A cystoscope was used to investigate, and the rest of the stent was found in the bladder.It was noted that the stent had detached between when it was initially placed on 10/11/23 until 11/01/23 when it was discovered via x-ray.There was no further harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, this device was obsolete in 2016 and has a 5-year shelf life.This means that all devices of this model would have been expired for a few years by now.It is likely the reported event occurred due to the use of an expired device could have contributed to this failure.However, because no lot number was provided and no device was returned, a specific root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SOF-CURL URETERAL STENT 6.0X24
• Type of Device: POLYMERIC URETERAL STENT
• 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: 18186991
• MDR Text Key: 328735768
• Report Number: 3003790304-2023-00434
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00821925005631
• UDI-Public: 00821925005631
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K930733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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
• Device Operator: Health Professional
• Device Model Number: 5626024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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