MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problems Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.Due to a pinhole on channel tube, water tightness was lost.In addition to the finds reported, adhesive on bending section cover had a chip.Due to wear of angle wire, bending angle in up direction did not meet the standard value.Connecting tube had a dent.The universal cord had a dent.Universal cord had a scratch.Video cable had a scratch.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Event Description

The customer reported to olympus, the uretero-reno videoscope had holes/air leaks.There was no report of patient harm associated with this event.During incoming inspection, it was determined foreign object came out of the suction channel.This is being submitted to capture the reportable malfunction found during evaluation.The customer was able to clean, disinfect and sterilize the subject device prior to requesting repair.The user facility does not know when the foreign object adhered to the scope.There was no delay with the start of pre-cleaning.Water was aspirated from the forceps/suction channel and instrument/suction channel.There was an unspecified abnormality in the accessories used for reprocessing.The forceps channel and instrument channel were brushed.The user facility has an endoscope reprocessor (oer) in the operating room and when in use, the vacuum takes place on the operating table, brush within a sink and washed with the washing machine.The facility does not think there is a reprocessing issue because the employee conducting the process has knowledge of endoscopy.

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, the root cause of the event was unable to be identified; however, it was confirmed that the foreign body emerged from the forceps channel.The foreign material was unable to be identified.Physical damage to the device may have resulted in the inability to remove the foreign body even if the process was performed appropriately.There was no deviation from the instructions for use in the client's re-process methodology.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation.

Event Description

Additional information was provided regarding this event.The event occurred during reprocessing.There were no user or patient harm associated with this event.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16195960
• MDR Text Key: 309024420
• Report Number: 3002808148-2023-00539
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2023

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 01/30/2023; 01/26/2023
• Supplement Dates FDA Received: 02/20/2023; 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• 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