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

Model Number CYF-VH

Device Problems Crack (1135); Peeled/Delaminated (1454); Pitted (1460)

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

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the cysto-nephro videoscope exhibited the bending section cover glue crack, a sharp chip and peeling.There were no reports of patient involvement.

Event Description

It was reported that the area where the insertion tube and bending section meet has a very sharp edge that could potentially damage a patient¿s urethra.The defect was observed before a cystoscopy procedure.It was confirmed that the scheduled procedure was completed.Although it was reported that the same device was not used to complete the procedure, it is unknown if a similar or different device was used.The incident caused a 10-minute procedural delay.There was no report of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was evaluated, and the bending section cover (a-rubber) was confirmed to be cracked/chipped/peeling.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been 3 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the reported defect (bending section cover crack/chipping/peeling) could not be identified.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ this supplemental report includes a correction to e2, e3, and g2 from the initial medwatch.An update has been made to h3.Also, information has been added to b5 and h4.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: 18966438
• MDR Text Key: 339142433
• Report Number: 3002808148-2024-02803
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/24/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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