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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS Back to Search Results
Model Number FD-412LR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided from the facility. The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined.
 
Event Description
Olympus medical systems corp. (omsc) received a literature title "efficacy of vonoprazan for the prevention of bleeding after gastric endoscopic submucosal dissection with continuous use of antiplatelet agents". The literature reported the result of 49 cases of the gastric endoscopic submucosal dissection (esd) procedures using an olympus model an insulated tipped (it) knife (kd-611l) and a coagrasper (fd-412lr) between december 2015 and june 2018. In the subject procedures, 1 case of post esd bleeding and 1 case of intraoperative perforation reportedly occurred. Based on the available information, a direct relationship between the subject devices and the observed reported adverse event could not be determined. According to the number of the accidental symptoms known and the number of olympus devices used for the procedure, omsc is submitting 4 medical device reports. This is the 2nd of 4 reports.
 
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Brand NameSINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
Type of DeviceSINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
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 Key10065490
MDR Text Key200605827
Report Number8010047-2020-02765
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K062517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
Type of Report Initial
Report Date 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberFD-412LR
Device Lot NumberUNKNOWN
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 Received04/21/2020
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: 05/18/2020 Patient Sequence Number: 1
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