MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE VIDEO SYSTEM CENTER

Model Number OTV-S190

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received by olympus for evaluation.The user facility report was confirmed and it was found that the digital output signal on the digital port was damaged.Additionally, found worn out lock latch mechanism on the video connector and old version main switch.

Event Description

The user facility reported that the digital visual interface (dvi) output on the device has been smashed.The reporter stated this occurred during preparation for use so there was no patient involvement.No additional information was provided.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr.The customer declined repairs and the device was returned unrepaired.The device repair history was reviewed which indicated the device was purchased on (b)(6) 2013 with no previous repair records.The original equipment manufacturer (oem), performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined to be due to the following: it is presumed that as approximately 7 years had passed since delivery of this product, this event was caused by deterioration due to long-term use, or that this event occurred because the user attempted to pull the video connector without lowering the locking lever or because excessive force was applied to the locking lever (video connector socket) or the video connector.Olympus will continue to monitor the field performance of this device.To mitigate device damage, the instruction manual of otv-s190 contains the following description.- properly and securely connect all cables.If the cable connector has a locking mechanism, such as connection screws, lock the cable connector.Otherwise, equipment damage or malfunction, such as no images on the monitor can result.- push the video connector into the video connector socket of the video system center all the way until it clicks, holding the video system center with a hand so that it will not move.Confirm that the ¿up¿ mark points upwards.- when an evis series endoscope is used, disconnect the scope side connector of the videoscope cable and place it on the scope cable holder.If disconnecting the video connector of the videoscope cable from the video system center while holding the video system center with a hand so that it does not move and pushing the locking lever down, place it on the side of the scope cable holder.

• Brand Name: VISERA ELITE VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10462935
• MDR Text Key: 204728888
• Report Number: 8010047-2020-05954
• Device Sequence Number: 1
• Product Code: FET
• Combination Product (y/n): N
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: OTV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1