MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. PROBE DRIVING UNIT

Model Number MAJ-1720

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been received by olympus for evaluation.The definitive cause for the customer's experience can not be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported while preparing for an unspecified procedure using a probe driving unit, the unit would not turn on.The device was inspected and no damage or abnormalities were noted.There was no patient injury related to this event.

Manufacturer Narrative

This report is being updated to report corrected information in b1, h1, and h10.B1: no device malfunction.H1: no device malfunction.This case has been determined to be a not-reportable device malfunction.There was no patient impact related to this occurrence.

• Brand Name: PROBE DRIVING UNIT
• Type of Device: PROBE DRIVING UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10868303
• MDR Text Key: 225940674
• Report Number: 8010047-2020-09160
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170311192
• UDI-Public: 04953170311192
• Combination Product (y/n): N
• PMA/PMN Number: K011886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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: Health Professional
• Device Model Number: MAJ-1720
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1