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

Model Number CYF-240

Device Problem Mechanical Problem (1384)

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the evis cysto videoscope was used with a 3-way adaptor (no issues in procedure), when cleaning postoperative, the adaptor was pulled out and the channel port came out with it.The issue was found during reprocessing, the intended procedure was completed with the same device.There were no reports of patient harm.No user injury reported.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that the biopsy port housing was lifted and tilting.Additional findings include the following: the control body biopsy port was loose and leaking, and the down angle was not to specification.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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 the subject device was shipped in accordance with specifications.A definitive root cause of the event could not be conclusively determined.However, based on the results of the investigation, possible cause is having applied excessive force and/or rotation stress to the biopsy channel port and/or the surrounding parts in combination use with maj-891 forceps/irrigation plug.The following information is stated in the instructions for use (ifu), which may help to prevent the issue: the suggested event is detectable by handling the device in accordance with the following ifu.- ifu of maj-891 states as follows: chapter 4 operation: to disconnect the forceps/irrigation plug, hold only the locking ring, and loosen it until it comes off the endoscope.Do not turn the plug¿s housing, as it may damage the plug and the endoscope.- ifu of cyf-240 states as follows: important information ¿ please read before use: repair and modification: do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer.Updated field: b5.

Event Description

The issue occurred during a cystoscopy procedure, and there was no delay.

• 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16969281
• MDR Text Key: 315827753
• Report Number: 9610595-2023-07787
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2023

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-240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 05/19/2023; 06/14/2023
• Supplement Dates FDA Received: 05/19/2023; 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2003
• 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