MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL UNIT

Model Number UES-40S

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

The subject ues-40's has not returned to olympus medical systems corp.(omsc) for evaluation yet.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the inspection of use of the ues-40's, when the user inspected the output of the subject device, the user felt electrical stimulation.There was no report of injury other than above.

Manufacturer Narrative

This is a supplemental report for mfr report.The subject ues-40s and hf- cable (wa00013a: made by olympus winter & ibe gmbh) was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject ues-40s, and there was no abnormality of the subject ues-40s.Omsc checked the device history record of the subject ues-40s, and there was no irregularity found.Omsc checked the subject wa00013a, the subject wa00013a was not conductive.It was considered that the conducting wires inside the subject wa00013a were almost breaking.Since the event was not reproduced, the exact cause has been unknown; however, the following are supposed to be the cause.The user felt a high frequency leakage current because the user touched the metal part of the unspecified resectoscope in a state where current flowed easily to the user.The user stimulated by the sparks generated internally cable due to the effect of conduction failure of the hf - cable.The instruction manual of the ues-40s states the corresponding method in case of an abnormality.

• Brand Name: ELECTROSURGICAL UNIT
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8407190
• MDR Text Key: 139544733
• Report Number: 8010047-2019-01242
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

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: UES-40S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1