• 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 KD-655

  • 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 KD-655 Back to Search Results
Model Number KD-655L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Event Description
Olympus reviewed the following literature titled "examination of treatment time with treatment tool for gastric esd". Literature summary: the devices mainly used for gastric esd at this hospital are itknife2, dualknifej, and flushknifebt. -s. Itknife2 is considered to have a shorter peeling time than the advanced system. If it can be resected reliably and safely, the treatment time will be shortened, which will reduce the burden on patients, the risk of accidents, and the burden on medical staff. We investigated the difference in treatment time depending on the device in the early cancer esd cases at our hospital. [type of adverse events / number of patients] 8 cases of post-operative bleeding. This article includes 2 reports for: patient identifier (b)(6) for kd-611l - we selected "kd-611l" as a representative product for itknife2. Patient identifier (b)(6) for kd-655l - we selected "kd-655l" as a representative product for dualknifej. This is report 2 of 2 for patient identifier (b)(6) for kd-655l - we selected "kd-655l" as a representative product for dualknifej.
 
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation. The investigation is in process. Date of event: the author responded the adverse events were not caused or contributed by the olympus device. The post-operative bleeding will remain a serious injury. The literature article is attached for additional information. Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE USE ELECTROSURGICAL KNIFE KD-655
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
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key14653160
MDR Text Key293709458
Report Number8010047-2022-09808
Device Sequence Number1
Product Code KNS
UDI-Device Identifier04953170405624
UDI-Public04953170405624
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K171158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-655L
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/15/2022
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

Patient Treatment Data
Date Received: 06/10/2022 Patient Sequence Number: 1
-
-