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

Model Number CHF-V

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc, but was returned to olympus (b)(4).During the evaluation by (b)(4), image loss reproduced when the bending section was angulated in the down direction.Other findings were as follows; the subject device passed the water leakage test.There was no trace of water intrusion inside of the bending section, control section, and venting connector of the subject device.There was no irregularity on the connecting points of the circuit board within the video connector.No solder defect was found on the cable connected to the ccd imager of the subject device.Image loss reproduced again and the bending section was angulated to the down direction when the video connector was replaced with another video connector.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the endoscopic image of the subject device disappeared when the user facility angulated the bending section of the subject device during a cholecystectomy procedure.The user facility completed the intended procedure with the subject device since the endoscopic image recovered by disconnecting and re-connecting of the video connector of the device to the video system center.The extension time of the procedure was less than 15 minutes.There was no report of patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide an evaluation result of the subject device.The insertion portion of the subject device has been returned to olympus medical systems corp.(omsc) for evaluation.During the evaluation, the reported phenomena reproduced when the bending section was angulated.It was found that the electric wire within the cable for the ccd was broken at 20 to 30 mm from the tip of the subject device.The insertion portion was disassembled, but no anomaly was found in the appearance and the location of the parts.It was concluded that the reported event occurred due to the damage of the electric wire for the ccd, however, the exact cause of the damage in the cable could not be conclusively determined as the returned device was incomplete.

• Brand Name: CHOLEDOCHO VIDEOSCOPE
• Type of Device: CHOLEDOCO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8251649
• MDR Text Key: 133536319
• Report Number: 8010047-2019-00862
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• PMA/PMN Number: K081456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

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: No Information
• Device Model Number: CHF-V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 02/25/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1