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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
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 lot number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. Based on the reported event, it is presumed that the reported complication was not due to the malfunction of the device.
 
Event Description
On april 27, 2020, olympus medical systems corp. (omsc) received literature titled ¿efficacy and suitable indication of colorectal endoscopic submucosal dissection using a balloon-assisted endoscope¿. In the literature, it was reported that intraoperative perforation occurred with two patients and post operative bleeding occurred with one patient. Two cases of perforation were conservatively managed by medical treatment after endoscopic closure using endoclips. The postoperative bleeding was managed conservatively using endoclips. The literature indicated that the electrosurgical knife (kd-650q or kd-620qr) might be used for the procedure. Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined. Therefore, omsc will submit 2 medical device reports (mdr) for each event. This report is 2 of 2 reports for the postoperative bleeding of the electrosurgical knife.
 
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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 Key10082666
MDR Text Key197998779
Report Number8010047-2020-02867
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,literatur
Reporter Occupation
Type of Report Initial
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
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 Received04/27/2020
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: 05/22/2020 Patient Sequence Number: 1
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