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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-655

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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 Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The subject device was not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided from the facility. However, omsc launched only products that had passed the inspection. The malfunction of the subject device concerning this case has not been reported, and there is no information indicating the relationship between this reported event and the subject device.
 
Event Description
Olympus medical systems corp. (omsc) received a literature title "ingenuity of esd procedure and treatment results for ulcerative colitis-related tumors". The literature reported the results of a study based on endoscopic submucosal dissection (esd) of 9 patients with ulcerative colitis between june, 2004 and september, 2019. During the study period, esd were performed with the use of the subject device (olympus single use electrosurgical knife), and an intraoperative perforation occurred in 1 patient and the procedure was abandoned. There is no description about the relationship between the subject device and adverse events, and no description about the severity or outcome of the adverse events.
 
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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 Key10624708
MDR Text Key210214273
Report Number8010047-2020-07193
Device Sequence Number1
Product Code KNS
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 literature
Reporter Occupation
Type of Report Initial
Report Date 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-655L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/10/2020
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 Unkown

Patient Treatment Data
Date Received: 10/04/2020 Patient Sequence Number: 1
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