• 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-620LR
Device Problem Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Death (1802); Hemorrhage/Bleeding (1888); Stomach Ulceration (4488)
Event Type  Injury  
Event Description
It is reported in the literature article titled "outcomes of per oral endoscopic pyloromyotomy in gastroparesis worldwide. " an unspecified number of patients experienced post procedural bleeding, pyloric ulcer, tension capnoperitoneum, or post procedural pulmonary embolism during or following a per oral endoscopic pyloromyotomy (poep) procedure. One patient death was reported not to be procedurally related. This article is a meta analysis of other research studies. The precise number of patients experiencing adverse effects as well as the treatment required was not provided. In the article, it doesn't specify which (or if any) olympus device was used in the procedures. It mentions two olympus devices as common choices for the procedure. Without specific details, one report will be submitted to report the possibility that an olympus triangle tip knife, or an olympus hook tip knife could have caused or contributed to the reported aes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key11416819
MDR Text Key246106792
Report Number2951238-2021-00296
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 02/01/2021,03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-620LR
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/01/2021
Event Location Hospital
Date Report to Manufacturer02/01/2021
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/04/2021 Patient Sequence Number: 1
-
-