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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE Back to Search Results
Model Number KD-611L
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2017
Event Type  Malfunction  
Manufacturer Narrative

The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The cutting knife broke off at approx. 4 mm from the distal end. The broken point was melted. The manufacturing record was reviewed and found no irregularities. Based on the similar cases in the past, it was known that the cutting knife might be broken off since electric discharge occurred and temperature of the cutting knife of the subject device increased while the high frequency output was activated. The instruction manual of the device has already warned as follows; when the electrosurgical unit is used in the coagulation mode, crack/detachment of the tip and the electrode or deformation/break of the cutting knife could occur, for example when the high-frequency output is set too high or the length of the contact between the cutting knife and tissue is too short. During treatment, always ensure that the slider slides on the handle smoothly and that the electrosurgical knife observed in the endoscopic image is normal. Should cracks or detachment of the tip or deformation/break of the cutting knife be detected during use, immediately shut off the power supply, discontinue the procedure, pull the slider and withdraw the endoscope from the patient with the cutting knife retreated in the insertion portion of this instrument. Do not continue using an abnormal electrosurgical knife to prevent perforation or hemorrhages. If the tip or cutting knife is detached be sure to collect it using grasping forceps.

 
Event Description

During an endoscopic submucosal dissection of the stomach, the subject device was used. In the procedure, the tip of the subject device was broken and fell off into the patient. The fragment was not retrieved. The procedure was completed with another device. There was no patient injury reported. This is the report regarding the breakage of the tip.

 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE
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
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key7150140
MDR Text Key96224017
Report Number8010047-2017-02136
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberPK092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberKD-611L
Device LOT Number73K
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/15/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/29/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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