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

Model Number URF-P6

Device Problem Break (1069)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus where service confirmed the customer's complaint. The device was repaired and returned to the customer. The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time. If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus the uretero-reno fiberscope had an image issue, "screen had black dots on the lens". Upon inspection and testing of the customer returned device, it was confirmed, due to metal sticking out of the pinholes in the bending rubber. This report is being submitted for the metal sticking out of the pinholes in the bending rubber, found during evaluation. There was no harm or user injury reported due to the event.

Manufacturer Narrative

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. Based on the results of the investigation, it is likely that excessive stress was applied to the bending section, which damaged the bending tube and caused the metal sticking out of the pinholes. User can detect the event by handling device according to the instruction for use: ¿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. ¿ user may prevent the event by handling device according to the instruction for use: ¿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
• MDR Report Key: 12507953
• MDR Text Key: 281649381
• Report Number: 8010047-2021-12091
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No