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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE Back to Search Results
Model Number KD-650Q
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bowel Perforation (2668)
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation. The definitive cause of the customer's experience cannot be determined at this time. The investigation is ongoing. This report will be updated upon completion of the investigation or upon receipt of additional relevant information. This reported event has been reported by the importer on mdr# 2951238 - 2020 - 00529.
 
Event 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.
 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key11078153
MDR Text Key224112264
Report Number8010047-2020-11038
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-650Q
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/21/2021
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 Reuse

Patient Treatment Data
Date Received: 12/28/2020 Patient Sequence Number: 1
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