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

Model Number KD-611L

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

Patient Problem Blood Loss (2597)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) since the device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot no.Is unknown, the manufacturing history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.From the reported information, we presume that the reported event was not due to the malfunction of the device, but occurred as a general complications of the procedure.

Event Description

In a multi-centered phase i study of feasibility in endoscopic hand suturing (ehs) of mucosal defects after gastric endoscopic submucosal dissection, the subject device was used.After the procedure endoscopic hand-stitched suture (ehs) was performed and completed the procedure.The next day hematemesis occurred.Emergency endoscopy was performed but no additional treatment was given since the bleeding had already stopped.There is no extension of hospitalization.The doctor commented that the bleeding was thought to be caused by esd because it was from ulcer.This is the report regarding hematemesis.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 8476845
• MDR Text Key: 140738640
• Report Number: 8010047-2019-01507
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092309
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: KD-611L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other