MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS CYSTO VIDEOSCOPE; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-240

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 10/03/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the light cover glass adhesive was uneven, the control body grip was damaged, the biopsy port was loose, the switch function was inoperative, the hot and cold test produced a misty image, and the down angulation was out of specification.Based on the initial evaluation of the device, the reported phenomenon was likely caused by user handling.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the evis cysto videoscope had the screw jammed on the port for the fluid side and it could not be unlocked.The issue was found during reprocessing.Inspection and testing of the returned device found the maj-891 connector jammed on the biopsy channel.When it was removed, it pulled the biopsy port out of its housing.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

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.Based on the results of the investigation, the root cause of the event was unable to be identified; however, the event most likely occurred due to the application of excessive stress to the maj-891 forceps plug mouthpiece attachment part when attaching or removing the maj-891.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS CYSTO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15697318
• MDR Text Key: 306910846
• Report Number: 9610595-2022-03471
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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-240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 11/25/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2009
• 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
• Treatment: MAJ-891-FORCEPS IRRIGATION PLUG.