MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problems Device Reprocessing Problem (1091); Scratched Material (3020)

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

Event Type  malfunction  

Event Description

The olympus representative (on behalf of the customer) reported to olympus, the uretero-reno fiberscope had an improper insertion of the forceps.The device was returned for evaluation.During the device evaluation, the following reportable malfunctions were found: the forceps channel port was shaved, and the distal end had foreign objects.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed, the forceps could not be inserted / the tube cleaning brush could not be inserted due to the clogging of the channel tube.The device evaluation found that the forceps channel port was shaved, and the distal end had foreign objects.The cleaning, disinfection, and sterilization (cds) was performed by the customer prior to the device being returned to olympus for repair, the customer did not know what the foreign material may be.It was unknown if there was a delay in the start of precleaning, it was unknown if there were any abnormalities in the accessories used for reprocessing, it was unknown if the customer presoaked the endoscope in the detergent solution, it was unknown if the customer wiped / brushed the distal end with clean lint-free cloths / brushes / sponges, and the customer did not have any concerns about the reprocessing.Additional findings include the following: the bending angle in the up direction did not meet the standard value due to wear of the angle wire, and the control unit had a crack.The following findings had a scratch: the eyepiece, diopter ring, control unit, grip, forceps elevator lever, angulation lever, up / down plate, and the connecting tube.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, it is likely the forceps channel port being shaved was caused by stress of repeated use, external factors, or the handling of the device; however, a definitive root cause could not be established.The cause of the foreign objects in the distal end could not be specified, since it was unknown if the reprocessing was conducted in accordance with the instructions for use (ifu) based off the obtained information.The following information is stated in the ifu (instructions for use) which may help to prevent the issue: the instruction manual operation manual ¿chapter 3 preparation and inspection, 3.3 inspection of the endoscope¿ describes the following : [inspection of the endoscope] 1.Inspect the eyepiece section and appearance of the control section for excessive scratching, deformation, loose parts, or other irregularities visually and with touching.2 inspect the eyepiece lens and the cover glass of the light guide connector for any irregularities such as scratches, cracks, and stains.3 inspect the boot and the insertion section near the boot for any irregularities such as bends, twists, tears, and cracks.4 inspect the external surface of the entire insertion section including the bending section and the distal end for any irregularities such as dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, and protruding objects.5.Holding the control section with one hand, carefully run your other hand back and forth over the entire length of the insertion section.Confirm that no objects or metallic wire protrude from the insertion section.Also, confirm that the insertion tube is not abnormally rigid.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17732427
• MDR Text Key: 323223767
• Report Number: 9610595-2023-13209
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/17/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• 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