MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Model Number FD-410LR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report has not yet been 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 Description

During an endoscopic submucosal dissection (esd) for stomach, the subject device was used.In the procedure, the patient's heart stopped and the patient fell unconscious.The intended procedure was cancelled, the user performed resuscitation treatment on the patient.Currently, the patient's heart is moving but the patient is unconscious.The user does not suspect the product as the cause of this event.This is the report regarding the unconscious of the patient.

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.The user did not report the malfunction of the device.Therefore, the exact cause of the reported event could not be conclusively determined.Omsc assumes that the cause of this event is not related to the malfunction of the device.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Type of Device: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8459300
• MDR Text Key: 140136262
• Report Number: 8010047-2019-01388
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K062517
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FD-410LR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening