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

Model Number URF-P6

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated at rrc (regional repair center) olympus (b)(4).During the initial inspection bending section breakage and perforation of the a-rubber were clearly identified showing a significant metal exposure.Tape was wrapped around the rubber of the distal end to seal the known leak as to perform properly the leak test.Further inspection of the device, the following findings were noted.Air leak of the a-rubber likely due to breakage of the bending section.Ig bundle breakages.Device evaluation showed the customer reported issue could be confirmed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, many black dots and tip leaks observed on the device.The issue found during reprocessing.There is no patient involvement associated on this reported event.No user injury reported.Device inspection found bending section breakage and perforation of the a-rubber were clearly identified showing a significant metal exposure.

Manufacturer Narrative

Correction to d9: the product was returned 23nov2021.Correction to g2: to add the foreign country switzerland.Correction to h3: the device manufacture date was 20nov2017.This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been 4 years, since the subject device was manufactured.Based on the results of the investigation, it is likely, that the excessive force applied to the bending section damaged the bending tube.The following is included in the instructions for use, (ifu) and can help detect the event: ¿precautions: perform a leakage test on the endoscope, after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may, also pose an infection control risk.Inspection of the endoscope: inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities¿.The following is included in the instructions for use, (ifu) and may have prevented the damage to the bending tube: "do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction, while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc., do not insert the insertion tube with excessive force and twist.Do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged".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: 13049235
• MDR Text Key: 284454949
• Report Number: 8010047-2021-16459
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• 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