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

Model Number CYF-VA2

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found the following: adhesive on bending section cover or distal sheath-rubber has a chip; connecting tube has a dent; connecting tube has a wrinkle; bending tube is deformed; image guide protector has a cut; 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 lens has a crack; video connector case has a scratch; electrical contact of video connector is shaved; video connector has a scratch; light guide cover glass has a scratch; light guide connector has a scratch; universal cord has a scratch; switch box has a scratch; angulation lever has a scratch; forceps elevator lever (surgical part) has a scratch; up/down angulation lever plate has a scratch; grip has a scratch; control unit has a scratch; bending tube is deformed; connecting tube has a wrinkle; connecting tube has a dent; due to damage on channel tube, channel cleaning brush cannot inserted smoothly; light guide lens has a crack; video cable has a scratch; video connector case has a scratch; and video connector has a scratch.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 shaved forceps channel port was confirmed through evaluation, a definitive root cause of the defect 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.

Event Description

The customer reported the tip of the visera cysto-nephro videoscope was collapsed.There were no reports of patient or user harm associated with this event.Inspection and testing of the returned device found the forceps channel port was scraped.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation.

• Brand Name: VISERA 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17441239
• MDR Text Key: 320210124
• Report Number: 3002808148-2023-07821
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339455
• UDI-Public: 04953170339455
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133538
• 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: 08/02/2023

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-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2013
• 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