MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETEROSCOPE SHEATH DILATOR

Model Number ST-U1

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus, during a uretero-dilation procedure, the subject device broke.The surgeon first tried to insert a ureteroscope through the renal fistula without using a ureter sheath, but failed.When a ureteral sheath was inserted through the renal fistula to dilate the ureter, the tip of the inner sheath broke.The broken part was recovered, but a 10mm foreign body was confirmed in the postoperative ct scan.It's suspected the foreign body on the ct scan was possibly part of the ureteral sheath.No treatment is given and the patient is being observed.The intended procedure was successfully completed.

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/lot 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, since the damaged part was detected at the distal end section of the device, stress at the timing of insertion likely caused the event.However, the root cause could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer.

Event Description

The customer responded to our request for additional information.When asked how the broken part was retrieved, the customer did not specify the instrument(s) used and stated, 'the broken part was retrieved from the nephrostomy.' it is unknown what ureteroscope was used during the therapeutic procedure.It is unknown when the device failed during the procedure.It is unknown if the device was inspected prior to the procedure.The same subject device was used to complete the procedure.There was a unknown delay in the procedure while the patient was under general anesthesia.When asked what the patient's status is today, the customer responded, 'no abnormality.'.

• Brand Name: URETEROSCOPE SHEATH DILATOR
• Type of Device: URETEROSCOPE SHEATH DILATOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15752321
• MDR Text Key: 303236499
• Report Number: 9610595-2022-03700
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K852888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2022

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: ST-U1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/22/2022; 12/01/2022
• Supplement Dates FDA Received: 11/22/2022; 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN URETEROSCOPE
• Patient Outcome(s): Other
• Patient Sex: Male