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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
Model Number KD-650Q
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); No Code Available (3191)
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 (b)(6) 2021, olympus medical systems corp. (omsc) received the literature titled "long-term outcomes of colorectal endoscopic submucosal dissection in elderly patients". This study was conducted the colorectal endoscopic submucosal dissection (esd) for 482 patients between (b)(6) 2005 to (b)(6) 2013. In the literature, it was reported that 30 patients of intraoperative perforations including a patient who required emergency surgery, one delayed perforation, one intraoperative bleeding who required emergency surgery, 8 patients of postoperative bleedings. And 18 patients were dead during the follow-up period. Based on the available information, the delayed perforation and the postoperative bleeding were not reported in a direct relationship with the olympus products. And, reported deaths were the cause of patient diseases. Therefore, it was no relationship between the event and the subject device. However, omsc assumes that the intraoperative perforation and the intraoperative bleeding might be related to the subject device since the subject device was used for esd. Based on the available information, detailed information on the subject device was not provided. There is no description of the device's malfunction. Omsc will submit two medical device reports (mdr) of the electrosurgical knife for the intraoperative perforation and the intraoperative bleeding. This is a report regarding intraoperative perforation.
 
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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 Key11184205
MDR Text Key230337571
Report Number8010047-2021-01545
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 literature
Reporter Occupation
Type of Report Initial
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-650Q
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 Received01/05/2021
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: 01/18/2021 Patient Sequence Number: 1
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