• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 10/19/2011
Event Type  Malfunction  
Manufacturer Narrative

The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The distal tip was broken. As the result of checking the manufacturing record of the same lot, there was nothing abnormal found. Based on the similar cases in the past, it was known that the distal tip might be broken, since electric discharge occurred and temperature of the distal tip increased while the high frequency output was activated. Also, it was known that electric discharge might occur, because the electro surgical unit was used in the coagulation mode, the high frequency setting value was too high, the activation time was too long, or the contact length between the cutting knife and the tissue was too short. The instruction manual of the subject device warns; 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

Olympus medical systems corp. (omsc) performed a mdr retrospective review and found that this report was required. During an endoscopic submucosal dissection, the doctor coagulated the tissue with the subject device. After that, he withdrew the subject device once, and he inserted it again. Then the distal tip of the subject device was broken, and a part of it was fallen off into the patient. The doctor retrieved the fragment. No patient injury was reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE USE ELECTROSURGICAL KNIFE
Type of DeviceELECTROSURGICAL KNIFE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951
ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA 192-8507
Manufacturer Contact
susumu nishina
2951
ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
426425177
MDR Report Key6207666
MDR Text Key63369842
Report Number8010047-2016-01616
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberKD-611L
Device LOT NumberK1808
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/25/2011
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/08/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-