MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES CHOLEDOCHOFIBERSCOPE; CHOLEDOCHO FIBERSCOPE

Model Number CHF-CB30L

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

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 9 years since the subject device was manufactured.Based on the results of the legal manufacturer¿s investigation, the rubber was torn off, likely due to the handling of the device and external factors.However, a definitive root cause could not be determined.During inspection and testing, service confirmed the customer's reported leak and found it was due to a break in the curved rubber, caused by external factors.In addition, the insertion tube and universal cord were crushed, and there was a stain on the image guide bundle.Paint on the control section was bubbling.Several of the device components demonstrated scratches from 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.

Event Description

The customer reported a pinhole leak.There was no patient or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.During inspection and testing, service found a piece of rubber covering had been torn off.This report is being submitted for the malfunction found by service during the device evaluation [adhesive detached].

• Brand Name: OES CHOLEDOCHOFIBERSCOPE
• Type of Device: CHOLEDOCHO FIBERSCOPE
• 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: 15131422
• MDR Text Key: 304438921
• Report Number: 9610595-2022-00445
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 04953170340154
• UDI-Public: 04953170340154
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• 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: 07/29/2022

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-CB30L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2013
• 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