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

Model Number CHF-V

Device Problem Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

The customer reported a leak in the bending rubber of the subject device.There was no patient or user injury reported due to the event.The device was returned to an olympus service center for evaluation.During inspection and testing, service found a leak due to perforations in the rubber covering.In addition, service observed the instrument channel port was rattling [loose] due to physical damage.This report is being submitted for the malfunction found by service during the device evaluation [damaged instrument channel port].

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 10 years since the subject device was manufactured.Based on the results of the legal manufacturer¿s investigation, the damage to the instrument channel port was likely due to stress applied during use of the device, and handling.However, a definitive root cause could not be determined.Upon further evaluation of the device, service found the insertion tube was crushed, and had wrinkles and scratches, due to external factors.The bending angulation was insufficient due to stretching of the angle wire.There was noise coming from the angle lever due to external factors.The adhesive from the rubber covering was chipped.The universal cord was crushed, due to external factors.Scratches were observed on the control section, grip, universal cord, video cable, video connector, light guide connector, and video connector case, due to external factors.Per the legal manufacturer, these other device issues identified by service have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15229446
• MDR Text Key: 304353932
• Report Number: 9610595-2022-00903
• 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: 08/15/2022

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: CHF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2012
• 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