MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VHA

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  

Event Description

A customer reported to olympus, the cysto-nephro videoscope displayed a scope communication error.There was no report of patient harm associated with this event.During incoming inspection, foreign matter came out the forceps channel due to insufficient cleaning.This medwatch is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of no image with a scope communication error was not confirmed.In addition to evaluation, due to damage on charge coupled device unit, e311 (white balance incomplete) error occurred.Due to a pinhole on bending section cover, water tightness was lost.Due to damage on charge coupled device unit, a noise image occurred.Due to breakage of image guide bundle, the image was not displayed.Due to discoloration of light guide bundle, illumination was uneven.Due to breakage of light guide bundle, illumination was poor.The light guide bundle was slipping down.Due to wear of angle wire, bending angle in up direction did not meet the standard value.Due to slipping down of light guide bundle, (narrow band imaging) nbi observation image was not bright enough.The control unit was sticky due to water leakage.The universal cord had a dent.The universal cord was sticky.The up/down plate was sticky.The connecting tube had a wrinkle.The connecting tube had a cut.The connecting tube had a dent.The adhesive on bending section cover had a chip.The distal end was shaved.The rubber cover of the forceps channel port was detached.Due to a dent on the bending tube, the joint section between bending tube and distal end was not secured.The video cable had a dent.The video cable had a scratch.Video connector case had a crack.Reprocessing of subject device: the customer was able to clean, disinfect and sterilize the subject device prior to sending it to olympus.User facility does not know when foreign object adhered to the scope.It is unknown whether the endoscope was used for a procedure with the foreign material attached.It is unknown if there was a delay between the end of clinical use and the start of pre-cleaning.It is unknown if water was aspirated through the instrument/suction channel.There were no abnormalities in the accessories used for reprocessing.It is unknown if the endoscope was immersed in a detergent solution.It is unknown if the instrument channel outlet was wiped/brushed with clean lint-free cloths, brush, or sponge.It is unknown if the instrument channel was brushed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).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 could not be determined.It was confirmed that foreign material was found in the forceps channel, however, the specific material could not be identified and the cause for the material remaining in the device could not be specified.It is likely foreign material remained in the device because it could not be removed due to physical damage.Furthermore, it is unknown if reprocessing was performed according to the instructions for use (ifu).The event can be prevented by following the instructions for use (ifu) which state: "·do not twist or bend the bending section with your hands.Equipment damage may result.·do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connector, and light guide connector.The endoscope may be damaged, and water leaks and/or breakage of internal parts like the image sensor cable can result." olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO 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: 16710398
• MDR Text Key: 313214808
• Report Number: 3002808148-2023-03566
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411274
• UDI-Public: 04953170411274
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• 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,Followup
• Report Date: 05/19/2023

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: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2019
• 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