MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CHOLEDOCHO VIDEOSCOPE; CHOLEDOCO VIDEOSCOPE

Model Number CHF-V

Device Problems Device Alarm System (1012); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found that the connecting tube is torn.Other findings includes: the biopsy channel is peeled off and leaked; the connecting tube is torn, leaked and rusty at many positions; the control section is rusty; the broken metal wires from the inside the insertion tube are sticking out.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the connecting tube on the choledocho videoscope is torn.The issue was found during preparation for use.The customer stopped the therapeutic, laparoscopic, endoscopic, laser lithotripsy procedure and delayed to another day.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.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 torn connecting tube was damaged during procedure, and the ensuing leakage test could not detect abnormality.The event can be detected/prevented by following the instructions for use which state: ¿chapter 5 reprocessing: general policy ¿ be sure to perform a leakage test on the endoscope prior to manual cleaning, and do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism or other malfunctions and poses an infection-control risk.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is to inform that in addition to the reportable malfunctions described in the initial report, the customer described the emergency lamp indicator was blinking.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the emergency lamp indicator was blinking.

• Brand Name: CHOLEDOCHO VIDEOSCOPE
• Type of Device: CHOLEDOCO 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: 18553272
• MDR Text Key: 333371286
• Report Number: 9610595-2024-01325
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K081456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

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: CHF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 01/02/2024; 02/15/2024
• Supplement Dates FDA Received: 01/22/2024; 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2019
• 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: CV-170 VIDEO SYSTEM CENTER