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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-620

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-620 Back to Search Results
Model Number KD-620LR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 03/29/2019
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. 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 due to the following reasons; the patient was taking an antithrombotic drug. The user is aware that bleeding is a possible complication of esd. The user did not report the malfunction of the device. The user suggested that physical stimulation such as meal may be the cause of bleeding.
 
Event Description
During a gastric endoscopic submucosal dissection (esd) for the patient who was taking an antithrombotic drug, the subject device was used. The procedure was completed without any issues. Three days after, the user observed the treatment site endoscopically, and found bleeding. The user performed endoscopic hemostasis. The patient was discharged on schedule. This is the report regarding the postoperative bleeding.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE KD-620
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 Key8534379
MDR Text Key142609956
Report Number8010047-2019-01750
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,study,use
Reporter Occupation
Type of Report Initial
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-620LR
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 Received04/10/2019
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: 04/21/2019 Patient Sequence Number: 1
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