• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. The exact cause could not be conclusively determined. However, based on the similar cases in the past, it was known that the distal tip might be broken and fallen into the patient, because electric discharge occurred and the strength of the knife was deteriorated due to high temperature given to the knife partly while the high frequency was activated. 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

On november 25, 2016, olympus medical systems corp. (omsc) found the literature which reported that the distal tip of the subject device was fallen off into the patient during an endoscopic submucosal dissection. The information was reported in the vol. 54 no. 11 p. 3610- p. 3618 of gastroenterological endoscopy. There was no information whether the fragment was retrieved or not. The intended procedure was completed with a different device. 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 Key6192018
MDR Text Key62914071
Report Number8010047-2016-01585
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 12/21/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberKD-611L
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2016
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

-
-