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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
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. Since the serial number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there is no description of the device's malfunction.
 
Event Description
On jun 15, 2020, olympus medical systems corp. (omsc) received literature titled "a case of gastric pseudoaneurysm following endoscopic submucosal dissection of early gastric cancer". In the literature, it was reported that bleeding and pseudoaneurysm were observed in a patient with the endoscopic submucosal dissection (esd). During esd, no muscular layer of damages or perforations were evident, and there was no bleeding that was difficult to stop. The esd procedure was performed using the electrosurgical knife (dualknife, it-knife). In the case of bleeding, hemostasis was performed using high-frequency hemostatic forceps (coagrasper g) and argon plasma coagulation (apc). The model number was not identified. Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined. However, in the literature, it was reported that high-frequency coagulation at the time of hemostasis during or after esd was considered to have the following influence. A penetrating vessel from the left gastric artery in the muscular layer at the mucosal defect may have collapsed, resulting in the formation of the pseudoaneurysm, which ruptured due to the influence of gastric acid. Therefore, omsc will submit 2 medical device reports (mdr) for each device. This report is 1 of 2 reports for the electrosurgical knife.
 
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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 Key10263866
MDR Text Key203109085
Report Number8010047-2020-04270
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K171158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/15/2020
Was Device Evaluated by Manufacturer? No
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: 07/13/2020 Patient Sequence Number: 1
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