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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE Back to Search Results
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.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE
Type of DeviceSINGLE 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 Key8476845
MDR Text Key140738640
Report Number8010047-2019-01507
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
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 Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-611L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/12/2019
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

Patient Treatment Data
Date Received: 04/03/2019 Patient Sequence Number: 1
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