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

Model Number URF-V2R

Device Problem Material Deformation (2976)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the issue was confirmed.The scope had failed the leak test due to a hole/cut of the cover of the bending section.The bending section had collapsed.The forceps and brush passage had buckling and deformation and were restricted.E2/e3: the occupation of the reporter is unknown.A supplemental report will be submitted should additional information be made available.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported by the customer, the uretero-reno videoscope had damaged rubber at the red tape.The issue was found at reprocessing.No patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the reporter.See updated sections.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.Based on the following information, it was likely that the cause of the issue was that the curved pipe was damaged by the user performing an operation in which an excessive force was applied to the curved part.According to the inspection result of the equipment, the curved pipe was damaged.According to the instruction for use (ifu), if the insertion part is pushed in with excessive force, the curved part may be damaged.According to a similar compact, the user performed an operation that applied excessive force to the curved part, the curved tube was damaged, and jumped out of the bending section cover.The curved tube is damaged by "when the user inserts the device into the lower renal calyx or ureter, the curved part is pushed in with excessive force while being bent".To prevent the occurrence of adverse events, the structure of the curved tube had been changed so that it will not damage the inside of the body cavity even if the curved tube was damaged.The instruction for use (ifu) states the following guidelines: 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.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 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.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 12320269
• MDR Text Key: 277661306
• Report Number: 8010047-2021-10222
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343612
• UDI-Public: 04953170343612
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• 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