MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE

Model Number URF-P5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Physical Entrapment (2327); No Information (3190)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

The reported scope was not returned to the service enter for evaluation; therefore, the cause of the reported event cannot be determined a this time.As part of our investigation, multiple follow-ups were made to the user facility in an attempt to gather additional information on the reported event; however, no additional information was obtained.However, if additional information becomes available, this report will be supplemented accordingly.This reported event has been reported by the importer on mdr# 2951238-2020-00313.

Event Description

On december 19, 2019, the service center received medwatch report # (b)(4) that states, "patient was undergoing a cystoscopy, right retrograde pyelogram, right ureteroscopy, laser lithotripsy procedure.As the surgeon proceeded to remove the ureteral scope from the right ureter it became lodged in the mid to distal ureter.The surgeon could not free the scope without significant traction.Despite attempts, the scope remained impacted within the ureter.A 14 french foley was replaced into the bladder, and ureteral scope was secured to patient's right thigh.The patient was then transferred to tertiary facility for further evaluation and management.".

Manufacturer Narrative

This report is being updated to provide additional information reported by the patient's attorney (reported in b5, b7), and corrected information (h6-health effect clinical code).

Event Description

Additional information received: the patient was hospitalized for a period of 4 days and the scope was able to be removed by the surgeon without surgical intervention.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer (lm) and to update the following sections: g3, g6, h2, h4, h6 and h10.The lm performed the device history records for the concerned device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A review of the repair history indicated that there was no repair history within the past year.A review of the complaint history indicates there are no similar complaints and no similar failures from the user facility.The investigation was completed by the lm and determined that there is no manufacturing, material or processing related cause for this failure mode.The concerned scope was not returned for evaluation; therefore, the exact cause of the reported malfunction could not be conclusively determined.Olympus will continue to monitor complaints for this device.

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9578354
• MDR Text Key: 189485954
• Report Number: 8010047-2020-00873
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170286988
• UDI-Public: 04953170286988
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 79