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

Model Number	5626024
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3003790304-2023-00434
• Device Sequence Number: 20642442
• Product Code: FAD
• UDI-Device Identifier: 00821925005631
• UDI-Public: 00821925005631
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K930733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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