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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-612

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-612 Back to Search Results
Model Number KD-612Q
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 09/04/2018
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation, because the subject device was discarded by the user. Therefore, the exact cause of the reported event could not be conclusively determined. The lot number of the subject device is unknown. Omsc has shipped only the products that passed the inspection. The operator informed that there was no abnormality in the subject device. This type of the event is most likely related to an accidental symptom. Omsc presumes that the event occurred due to either following occurrence mechanism. Output setting of high-frequency cautery power supply unit was higher than necessary. Activation time was longer than necessary. The dissection was performed in the absence of enough elevating the mucosa. Activation without aspiration of bodily fluid. During activation, the distal end of endoscope was angled abruptly. The dissection was performed while the triangular tip or knife was pushed. Incising tissue too deeply. The tissue was incised and coagulated without activation. Situation of patient (organization).
 
Event Description
During an endoscopic submucosal dissection, the subject device was used. In the procedure, bleeding occurred, and hemostasis was performed using hemostasis forceps. The user sutured the bleeding region and completed the intended procedure. Since bleeding was discovered at a later date, an endoscopic hemostasis procedure was performed. The patient was recovered. This is the report regarding the postoperative bleeding.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE KD-612
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 Key8040523
MDR Text Key126219534
Report Number8010047-2018-02118
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-612Q
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 Received10/16/2018
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 Initial

Patient Treatment Data
Date Received: 11/05/2018 Patient Sequence Number: 1
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