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

Model Number URF-P6

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Event Description

The customer reported to olympus the uretero-reno fiberscope, had a dark screen.The issue occurred during an unknown event.The procedure was unknown.There were no reports of patient or user harm associated with this event.Inspection and testing of the returned device found that the forceps plug mouthpiece is scraped.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the following: due to breakage of light guide bundle, illumination is uneven; forceps channel port is shaved; due to a dent on distal end, water tightness is lost; due to a pinhole on bending section cover or distal sheath rubber, water tightness is lost; distal end has a burn; adhesive on bending section cover or distal sheath rubber has a chip; due to wear of angle wire, bending angle in upwards direction does not meet the standard value; due to damage on channel tube, forceps cannot be inserted smoothly; due to damage on channel tube, channel cleaning brush cannot inserted smoothly; light guide bundle has breakage; bending tube is damaged; connecting tube has a scratch; forceps elevation lever (surgical part) has a scratch; upwards/downwards plate has a scratch; venting connector under grip is shaved; grip has a scratch; control unit has a scratch; diopter ring has a scratch; eyepiece has a scratch; angulation lever has a scratch; due to a dent on distal end, water tightness is lost; and light guide bundle has breakage.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.Although it was determined that the defect was likely caused by stress of repeated use, external factors, or handling, a definitive root cause of the shaved channel port could not be identified.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of 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: 17324218
• MDR Text Key: 319020237
• Report Number: 9610595-2023-10111
• 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: 07/14/2023

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: 06/19/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2018
• 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