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

Model Number URF-P7

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the olympus' regional repair center (rrc) for evaluation.An air leak was noted at the scope¿s biopsy channel.The distal end cap was found burnt.The insertion tube was noted to be broken.Paint was noted to be peeling off the control grip unit.Light guide bundle breakage was noted causing uneven illumination.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.

Event Description

The customer reported that after the conclusion of an unspecified procedure, the sheath detached from the scope¿s tip.There was no patient injury reported.

Manufacturer Narrative

This report is being supplemented to provide a correction for g2 and h4.This report also includes additional information based on the legal manufacturer's final investigation.G2 - checked 'other' to add the country italy.H4 - corrected device manufacturer date to november 8, 2018.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the cause of the sheath detaching from the scope tip likely occurred from user handling the device during the procedure.The specific root cause of the user handling could not be determined at this time.The following information is stated in the instructions for use regarding proper handling of the device which may have prevented the event: "preparation and inspection - inspection of the endoscope: inspect the entire distal end of the endoscope including the objective lens and examination light outlet for any irregularities such as scratches, chips, cracks, stains, discoloration, deformation, and gaps around the lens.Operation - using the laser system: warning: do not irradiate the laser without viewing the tip of the laser probe and the aiming beam in the endoscopic image.This may cause patient injury, and the instrument channel may be damaged.Do not withdraw the laser probe while irradiating the laser.Patient injury and/or endoscope damage may occur." olympus will continue to monitor field performance for this device.

• Brand Name: 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12658125
• MDR Text Key: 277211341
• Report Number: 8010047-2021-13350
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• 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