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

Model Number CYF-VA2

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the visera cysto-nephro videoscope, had rubber change.The issue occurred during a procedure.The procedure was diagnostic.There were no reports of patient or user harm associated with this event.Inspection and testing of the returned device found that there were defects in the insertion tube.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during the evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to clarify b5 reportable malfunction.Correction to d8/d9 for information inadvertently left out of previous report.Correction to e2 which was inadvertently checked; reporters title is not available.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 definitive root cause of the event cannot be determined.The event can be prevented by following the instructions for use which state: "¿ do not coil the insertion tube, universal cord, or video cable into a diameter of less than 10 cm.Equipment damage can result.¿ do not apply shock to the distal end of the insertion tube, particularly the objective lens surface at the distal end.Visual abnormalities may result.¿ 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 leading to fluid invasion into the endoscope.¿ do not hit or bend the electrical contacts on the video connector.The connection to the video system center may be impaired and faulty contact can result.¿ do not insert the video connector while the electrical contacts are wet and/or dirty.Doing so may result in electric shock, causing severe damage to the endoscope and compromising patient and/or operator safety." olympus will continue to monitor field performance for this device.

Event Description

Clarification to the purpose of this medwatch report: - inspection and testing of the returned device found the bending section adhesive was cut.This report was submitted to capture the reportable malfunctions found during the evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found the following: due to pinching on bending section cover or distal sheath rubber, water tightness is lost; adhesive on bending section cover or distal sheath rubber has a chip; bending section cover or distal sheath rubber has a cut; connecting tube has a buckling; and connecting tube is snaking.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

• 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: 17853665
• MDR Text Key: 324724245
• Report Number: 3002808148-2023-10624
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170287145
• UDI-Public: 04953170287145
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/05/2023; 10/24/2023
• Supplement Dates FDA Received: 10/05/2023; 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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