MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-612

Model Number KD-612Q

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

Patient Problem No Code Available (3191)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.Omsc has shipped only the products that passed the inspection.The operator informed that there was no abnormality in the subject device.This type of the event is most likely related to an accidental symptom.Omsc presumes that the event occurred due to either following occurrence mechanism.Output setting of high-frequency cautery power supply unit was higher than necessary.Activation time was longer than necessary.The dissection was performed in the absence of enough elevating the mucosa.Activation without aspiration of bodily fluid.During activation, the distal end of endoscope was angled abruptly.The dissection was performed while the triangular tip or knife was pushed.Incising tissue too deeply.The tissue was incised and coagulated without activation.Situation of patient (organization).

Event Description

During an endoscopic submucosal dissection, the subject device was used.In the procedure, bleeding occurred, and hemostasis was performed using hemostasis forceps.The user sutured the bleeding region and completed the intended procedure.Since bleeding was discovered at a later date, an endoscopic hemostasis procedure was performed.The patient was recovered.This is the report regarding the postoperative bleeding.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-612
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8040523
• MDR Text Key: 126219534
• Report Number: 8010047-2018-02118
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-612Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention