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

Model Number	MAJ-1720
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 8010047-2020-09160
• Device Sequence Number: 2635835
• Product Code: ITX
• UDI-Device Identifier: 04953170311192
• UDI-Public: 04953170311192
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K011886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: MAJ-1720
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1