MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VHA

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility requested an investigation into whether the white foreign material was caused by the device and whether there was any abnormality in the device.The device was returned to omsc for evaluation.Omsc inspected the device and confirmed the following: there were no visible defects on the appearance of the device.From the photos provided by the user facility, omsc confirmed that there was a white foreign material on the distal end.Omsc checked the appearance of the device and confirmed that there were no white foreign material on it.The adhesive of the bending section rubber was chipped.There was a leakage from the distal end.When the device was connected and operated according to the instruction manual, there were no abnormalities.Omsc requested olympus service operation repair center (sorc) to inspect the device, and sorc confirmed the following: there was a leakage from the distal end.The angulation was insufficient.There was rattling in the bending tube.There was a gap in the instrument channel port the indicator of the grip unit had disappeared.The up/down plate, control section, grip unit, universal cord, video connector, tube, and light guide connector were scratched.From the device repair history, omsc confirmed that the bending section rubber, light guide lens, flexible tube, and bending section tube were replaced on june 25, 2020.The reported event may have been caused by the failure to remove the debris because reprocessing could not be performed normally due to leakage.The instruction manual provides how to inspect the device.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that after cleaning and disinfection was complete, white string-like debris came out of the device.When the white foreign material came out of the device, the user facility decided to continue using the device without reporting the event to olympus.However, the user reported to olympus because the event recurred.The white foreign material disappeared after cleaning and disinfection.The device was reprocessed with a non-olympus automated endoscope reprocessor, endoclens.There was no report of patient injury associated with the event.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• 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: 12179069
• MDR Text Key: 267524660
• Report Number: 8010047-2021-08940
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/16/2021

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-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1