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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-650

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650 Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); 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 december 7, 2020, olympus medical systems corp. (omsc) received the literature titled "comparison of short-term efficacy between endoscopic submucosal tunnel dissection and endoscopic submucosal dissection in treatment of wide esophageal squamous cell carcinoma of early stage". This study was conducted endoscopic submucosal tunnel dissection (estd) with endoscopic submucosal dissection (esd) for 40 patients with early-stage esophageal squamous cancer between january 2014 to december 2016. In the literature, it was reported that bleeding, perforation, stenosis, additional surgery, fever, and mediastinal emphysema have occurred. The additional surgery patient was an esophagectomy due to pathologic incomplete resection. Therefore, it was no relationship between the event and the subject device. Based on the available information, detailed information of the subject device was not provided, and there is no description of the relationship between the events and the subject device. However, omsc assumes that the perforation and the bleeding might be related to the subject device since the subject device was used for submucosal resection. There is no description of the device's malfunction. Omsc will submit one medical device report (mdr) for the type of the device (electrosurgical knife).
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE KD-650
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 Key11044013
MDR Text Key227203065
Report Number8010047-2020-10723
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,literature
Reporter Occupation
Type of Report Initial
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/07/2020
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: 12/21/2020 Patient Sequence Number: 1
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