MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CHOLEDOCHO VIDEOSCOPE; CHOLEDOCO VIDEOSCOPE

Model Number CHF-V

Device Problem Break (1069)

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

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility returned the device to olympus for repair due to a leakage from the bending section rubber during reprocessing.The device was used for choledocholithotomy in combination with the video system center otv-s190.The procedure was completed without delay for more than 15 minutes.The device was evaluated at ocsm.As a result of the evaluation, the following was confirmed.-the bending section rubber was damaged and there was a leakage from the bending section rubber.-the angulation was insufficient.-the protector of the universal cord was damaged.-the device has not been repaired in the last year.Olympus medical systems corp.(omsc) confirmed the following from the photos provided by ocsm: -the adhesive of the bending section rubber was chipped.-the insertion section was scratched.Omsc confirmed the result of the device evaluation, but could not identify any defects that could affect the occurrence of the reported event.The exact cause of the reported event could not be conclusively determined.However, based upon the past similar cases, the reported event may have been caused by the following effects, etc.-physical stress -chemical stress -poor storage environment (direct sunlight, high temperature, high humidity, environment exposed to x-rays and ultraviolet rays, etc.) omsc determined that the reported event could be prevented because the instruction manual provides precautions regarding the handling of the insertion tube, and storage of the device.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

Event Description

Olympus inspected the device at the service department of olympus (b)(4) and found that the coating of the insertion section was peeled off.There was no report of patient injury associated with the event.

• Brand Name: CHOLEDOCHO VIDEOSCOPE
• Type of Device: CHOLEDOCO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12931859
• MDR Text Key: 285635006
• Report Number: 8010047-2021-15538
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2021
• 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: 11/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1