MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FOOT SWITCH

Model Number	MAJ-1243
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During an unspecified procedure, the subject device was used in combination with sonosurg generator.In the procedure, an abnormal noise from the generator occurred and the generator could not output.The user exchanged the subject device for another device.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the output fault of the subject device.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device and sonosurg-g2 were returned to olympus medical systems corp.(omsc) for evaluation.The subject device was checked in combination with the sonosurg-g2 and failure output was confirmed when the cord was bent during activation.The serial number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the event date, it was found no irregularities.Based on the past similar cases, omsc assumes that an output failure might occur since the cord was disconnected.Also, the cord might disconnect since the cord was subjected to a repetitive bending load.The above device handling has warned in the instruction manual of sonosurg-g2 as follows.*do not excessively bend, twist, press or strain any of the cords, as doing so may damage the cords or the wires inside them.

• Brand Name: FOOT SWITCH
• Common Device Name: FOOT SWITCH
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9584465
• Report Number: 8010047-2020-00882
• Device Sequence Number: 19586209
• Product Code: LFL
• UDI-Device Identifier: 04953170170492
• UDI-Public: 04953170170492
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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-1243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1