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

Model Number URF-P7R

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

Further inspection of the returned device noted a leak on the bending section rubber at the distal end plastic portion of the control body.The bending section glue was found lifted on the scope¿s cover and insertion tube.The cause of the physical scope damage cannot be determined at this.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 the scope failed the leak test.There was no patient involvement reported.In addition, during estimation a bending support pin was found detached and protruding through the bending section rubber with a sharp edge making this a reportable event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and the lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The legal manufacturer provided the following possible cause for the reported event: the legal manufacture presumed that the user manipulated the device so as to apply excessive stress to the bending section, which caused the bending tube to break and cable support to protrude from the bending section rubber.The instructions for use (ifu) contains the following statements that may help detect the reported 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 ifu contains the following statements that may help reduce or prevent the occurrence of the reported event: -"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." in addition, the legal manufacturer reported that this phenomenon has occurred when the user forcibly angulates the distal end toward the opposite direction while the distal end is bent and unable to move in calix.A countermeasure was placed to prevent an adverse event, which included the design change of the bending tube to not damage the inside of body, even if bending tube gets broken.The legal manufacturer confirmed via device history review (dhr) that the device was shipped out in accordance to specifications.Olympus will continue to monitor for similar events.

• 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
• MDR Report Key: 12235380
• MDR Text Key: 266035440
• Report Number: 8010047-2021-09440
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403835
• UDI-Public: 04953170403835
• Combination Product (y/n): N
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1