MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ISOLATIONTRANSFORMER 100V

Model Number	MB-631
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Olympus medical systems corp.(omsc) could not investigate the device, because the device was not returned to omsc.Based upon the information from complaint, omsc confirmed that the sheathing of the root of the power cord was broken.Since the device was not returned, the exact cause was unknown.Omsc surmised that the reported phenomenon was occurred because the excessive force was applied to the power chord or a sharp object touched the power chord.
Event or Problem Description
Olympus service operation repair center was informed from the facility that in unspecified timing the power cord of the device was broken.Other detailed information was not provided.There was no report of patient injury associated with the event.

• Brand Name: ISOLATIONTRANSFORMER 100V
• Common Device Name: TRANSFORMER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11200103
• Report Number: 8010047-2021-01634
• Device Sequence Number: 2231257
• Product Code: FET
• UDI-Device Identifier: 04953170026669
• UDI-Public: 04953170026669
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• 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
• Report Date (Section B): 01/20/2021

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: No Information
• Device Model Number: MB-631
• Device Lot Number: 19891
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1