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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-620LR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc). 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 accidental symptom was not due to the malfunction of the device, but occurred as a general accidental symptom of the procedure.
 
Event Description
On august 7th, 2019, olympus medical systems corp. (omsc) received a literature titled ¿value of endoscopic ultrasonography in diagnosis of gastric stromal tumor and the application of endoscopic submucosal excavation in the treatment of gastric stromal tumor¿. The literature reported that 29 procedures of endoscopic submucosal dissection (esd) were performed using olympus single use electrosurgical knife (kd-620lr or kd-611l) between december 2012 and october 2013. The literature reported that symptoms occurred as follows; mild bleeding: 29 cases. They were managed by ar. Gon plasma coagulation or hot biopsy. In one case small artery ejection bleeding occurred and hemostatic clip was used to close the bleeding. Perforation: 3 cases. The users were sealed by titanium clip and/or nylon ring. All patients received diet control, gastrointestinal decompression, anti-infection and other treatments. Conservative medical treatment was successful. Omsc tried to obtain further information such as the relationship between olympus device and all of the reported symptoms, but it is not obtained from the author of this literature at present. Therefore, according to the number of the type of symptoms known and the number of olympus device used for procedure, omsc is submitting 4 medical device reports. This is a report on mild bleeding associated with kd-620lr, and 1 of 4 reports.
 
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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 Key8954836
MDR Text Key161259281
Report Number8010047-2019-03166
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 09/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
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 Received08/07/2019
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: 09/03/2019 Patient Sequence Number: 1
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