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

Model Number CYF-V2

Device Problems Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

It was reported that the nephro videoscope's bending rubber was broken, torn, and ruptured, and the metal was sticking out.The issue occurred during preparation for use in a diagnostic procedure.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the evaluation found that there was a torn, adhesive removed per process.Advanced diagnostics performed by a borescope and found a tear inside the channel wall.Unable to perform the test due to a torn bending section cover or distal sheath.Leak tested and no other leaks were found.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Three good faith effort (gfe) attempts were made and a response from the customer was not received.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, a probable cause could not be determined.The event can be detected/prevented by following the instructions for use which state: "do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, and control section with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.Do not damage the endoscope¿s distal end, insertion tube, bending section, video connector, and light-guide connector when you transport and reprocess the endoscope.Do not coil the insertion tube, universal cord, or video cable into a diameter of less than 10 cm.Equipment damage can result".Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18668172
• MDR Text Key: 336057231
• Report Number: 3002808148-2024-01216
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411199
• UDI-Public: 04953170411199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• 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