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 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus (b)(4) but has not been returned to omsc.Olympus (b)(4) checked the subject device for evaluation.It was confirmed that the coating on insertion tube of the subject device was peeled off due to deterioration.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based upon the information from olympus (b)(4), past similar case and instruction manual, omsc surmised that the reported phenomenon was attributed to physical stress, chemical stress and/or storage environment.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus (b)(4), it was found that the insertion tube of the subject device was peeled off.The subject device had been returned to olympus (b)(4) for repair of the leakage at the bending section.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: 12758694
• MDR Text Key: 281836149
• Report Number: 8010047-2021-14154
• 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: 11/05/2021

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 Model Number: CHF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2021
• Initial Date FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1