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

Model Number CHF-V

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation, omsc confirmed the endoscopic image disappeared when the bending section was angulated.The insertion tube of the subject device was crushed due to physical damage.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The subject device has no repair history for approximately six years.The cause of the reported event could not be conclusively determined.However, the possible cause of the reported event might be aging deterioration or the broken electrical components within the insertion tube.The electrical components possibly broke due to physical damage which was applied when the insertion tube was crushed.The operation manual has already warned; ¿do not bend, hit or twist the insertion section, control section, universal cord and video connector.The endoscope may be damaged and water leaks and/or breakage of internal parts like the ccd cable can result.¿ if additional information is received, this report will be supplemented.

Event Description

Olympus was informed that the endoscopic image of the subject device was disappeared during an unspecified therapeutic procedure.Since the event occurred at the end of the procedure, the facility completed the procedure without replacing the subject device.There was no report of patient injury associated with this report.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code.".

• Brand Name: CHOLEDOCHO VIDEOSCOPE
• Type of Device: CHOLEDOCO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7078194
• MDR Text Key: 93734211
• Report Number: 8010047-2017-01901
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK081456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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: Physician
• Device Model Number: CHF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/03/2017
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2011
• 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