Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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-650Q
Health Effect - Clinical Code Bowel Perforation (2668)
Type of Reportable Event Serious Injury
Event or Problem Description
It is reported in the literature article titled "esd with double-balloon endoluminal intervention platform versus standard esd for management of colon polyps" appearing in the aug 2020 issue of endoscopy international, following a colonoscopy with double balloon endoluminal intervention using a pentax single-channel video endoscope, an olympus disposable distal cap, and an olympus single use electrosurgical knife, one patient experienced a bowel perforation.No information was provided regarding any treatment required as a result of this occurrence.There was no report of any olympus device malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SINGLE USE ELECTROSURGICAL KNIFE
Common Device Name
SINGLE USE ELECTROSURGICAL KNIFE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key11078069
Report Number2951238-2020-00529
Device Sequence Number3561767
Product Code KNS
UDI-Device Identifier04953170265778
UDI-Public04953170265778
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/28/2020
Report Date (Section F) 11/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberKD-650Q
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/29/2020
Date Report to Manufacturer11/29/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-