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

Model Number	MAJ-1258
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject foot switch maj-1258 has not returned to olympus medical systems corp.(omsc) for evaluation yet.Omsc investigate the subject foot switch maj-1258 to determine the cause of this phenomenon when omsc receives it.There were no further details provided.If significant additional information is received, this report will be supplemented.
Event or Problem Description
During the unspecified procedure with the subject foot switch maj-1258 and ues-40, the user pressed the pedal of the subject foot switch maj-1258 to activate the high frequency output, however the high frequency output was not activated.The user replaced the foot switch maj-1258 and ues-40 to another unspecified device to complete the procedure.During the inspection of the user with the subject foot switch maj-1258 and ues-40, when the user pressed the pedal of the subject foot switch maj-1258, the user received a small electric shock.The local service engineer reported the following inspection result of the subject foot switch maj-1258 and ues-40.The insulation of outside of lead wire of the subject foot switch maj-1258 had been pulled away from the lead wire.There was no abnormality of the ues-40.There was no report of the injury other than above.
Additional Manufacturer Narrative
This is a supplemental report for mfr report #8010047-2019-04231.The subject device maj-1258 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject device and found that the covering of the cable of the subject device was peeled off and the core line was exposed.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.It was considered that the electrical shock was attributed to the contact of the body of the subject device and the exposed core line.In addition, it was considered that the failure of the subject device was attributed to the damage the cable of the subject device.Omsc surmised that the damage of the cable was attributed to mechanical stress due to the inappropriate user handling.The instruction manual of the subject device states the corresponding method in case of an abnormality.

• 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: 9448984
• Report Number: 8010047-2019-04231
• Device Sequence Number: 2159412
• Product Code: GEI
• UDI-Device Identifier: 04953170165481
• UDI-Public: 04953170165481
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAJ-1258
• Device Lot Number: 09033
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other