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

Model Number OTV-S190

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation.Evaluation determined that the device was found to have a bent video connector pin on the panel connection.The identified parts were replaced, device was repaired.Once completed, the device was tested and passed all required testing and specifications.Based on the evaluation findings, the reported issue was confirmed.The root cause of the issue was attributed to mishandling.The bent pins were replaced, device was repaired and issue was resolved.

Event Description

It was reported that during preparation for use, the device was found to have a damaged pin on the panel connection.There was no patient involvement on this report.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue was not identified.It was presumed that the reported failure could be due to the terminal buckling inside the video connectors occurred when inserting the scope internal into the scope connector socket of otv-s190, the missing part of the scope connector tip was caught in the terminal inside the scope connector socket of otv-s190.The terminal inside the scope status socket of otv-s190 was pushed back and the terminal buckled because the scope connector was further inserted with the inserted scope connector caught.Olympus will continue to monitor complaints for this device.

• 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: 10181241
• MDR Text Key: 223475290
• Report Number: 8010047-2020-03550
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1