MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. P CORD; PATIENT CORD

Model Number	MAJ-814
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject maj-814 was not returned to olympus medical systems corp.(omsc) yet.Omsc will investigate the subject maj-814 to identify the root cause of this failure phenomenon when omsc receives it.The exact cause of the reported event could not be conclusively determined at this time.The maj-814 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.
Event or Problem Description
The user attached the patient plate (electrode plate) on the right buttock of the patient in the endoscopic procedure of using high frequency current.During the procedure, the patient felt a sense of numbness.There was no problem that attachment of the patient plate on the patient's body, and connection of the patient plate and the subject maj-814.There was no report of the patient¿s injury regarding this event.
Additional Manufacturer Narrative
Omsc evaluated the subject maj-814 and found that the foreign material was adhered at the connector of the subject maj-814.However, the exact cause of the reported event could not be conclusively determined.According to the literature, it is known as common complication of high-frequency procedure that a patient feels pain, especially at the following situation.During high-frequency procedure, dc pulse current was occurred by the rectifying action at the time of spark generation.Or, the patient's body touched the operating table, and the high frequency current from the electrosurgical knife was diverted to the contact point.There are adhesion near the treatment site.Therefore, there is possibility of this phenomenon is attributed to the common complication.Olympus stated the appropriate handling of the maj-814 and the counter-measures against the irregularity in the instruction manual.There were no further details provided.If significant additional information is received, this report will be supplemented.

• Brand Name: P CORD
• Common Device Name: PATIENT CORD
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8145290
• Report Number: 8010047-2018-02384
• Device Sequence Number: 16567386
• Product Code: GEI
• UDI-Device Identifier: 04953170078361
• UDI-Public: 04953170078361
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K021852
• 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): 03/27/2019

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
• Operator of Device: Other
• Device Model Number: MAJ-814
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 12/09/2018
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1