MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", EUROPEAN VERSION; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problems Break (1069); Defective Device (2588)

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

Event Type  malfunction  

Event Description

Customer reported defects of the bending section and insertion tube.The issue found at reprocessing.There is no patient involvement associated on this reported event.No user injury reported.Device return evaluation found device bending rubber cover broken, separated (increased outside diameter).

Manufacturer Narrative

The subject device was received and evaluated at rrc (regional repair center) olympus prerov.Device return inspection found broken bending rubber cover (increased outside diameter.In addition, leak was observed in the a-rubber (bending section), bending tube separated.Chemical damage and stains were noted on the insertion tube and protector and video connector tube.The plug unit was observed with corrosion.Based on evaluation findings the reported customer issue was confirmed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

Correction to g2 to add the foreign country italy.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been 11 years since the subject device was manufactured.Based on the results of the investigation, it is not possible to determine whether the observed damage was due to stress, handling, or other factors.The following is included in the instructions for use (ifu) under "preparation and inspection" and can help detect the damage: "before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.If this instrument malfunctions, do not use it.Return it to olympus for repair as described in section 9.3, "returning the endoscope for repair" on page 123.If any irregularity is observed after inspection, follow the instructions given in chapter 9, "troubleshooting"." the following warning is also provided in the device's ifu: "using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage." olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE "CYF-V2", EUROPEAN VERSION
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12861675
• MDR Text Key: 281163635
• Report Number: 8010047-2021-14935
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• 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
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2010
• 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