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

Model Number CHF-V

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

The customer reported to olympus medical that the choledocho videoscope's insertion section leaked due to a defect in the bending section cover.The device was returned for evaluation.During examination, the device showed the forceps channel port was not secure in the forceps channel.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.No adverse effects to patient reported.

Manufacturer Narrative

The device was returned to olympus for evaluation.In addition to the loose forceps portal, the grip cover was chipped.Due to a cut on bending section cover (a-rubber), water tightness was lost; adhesive on bending section cover (a-rubber) had a chip; connecting tube had a wrinkle; image guide protector had a cut; due to wear of angle wire, bending angle in the upward direction did not meet the standard value; bending tube was damaged; and scratches were found on multiple components of the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, it is likely that a stress issue led to the malfunction (forceps channel port damage).The overall cause of the stress was not confirmed.The device instructions for use document was reviewed.Review showed the following relevant instruction related to inspection for damage in section 3.6: ¿inspection of the endoscopic system: 1.Turn the tightening knob to align the end faces of the biopsy valve and the tightening knob.2.Insert the distal end of the endotherapy accessory into the forceps port.3.Pass the endotherapy accessory through the channel and confirm that it extends smoothly from the distal end of the endoscope." olympus will continue to monitor field performance for this device.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17322527
• MDR Text Key: 319681167
• Report Number: 9610595-2023-10105
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2023

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: CHF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2012
• 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