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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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp (omsc) for evaluation. Since the lot no. Is unknown, the manufacturing history record (dhr) could not be reviewed. However, omsc has only shipped devices which passed the following inspections. Length of the cutting knife. Dc resistance value between plug to cutting knife. Operation of the cutting knife. There was no malfunction report of the subject device concerning the events. The exact cause of the reported event could not be conclusively determined. If additional information becomes available, this report will be supplemented.
 
Event Description
On january 15th, 2020, olympus medical systems corp. (omsc) received a literature titled ¿the utility of a novel colonoscope with retroflexion for colorectal endoscopic submucosal dissection¿. The literature reported results of two hundred and twenty-seven procedures of endoscopic submucosal dissection (esd) to resect colorectal lesions located in the left-side colon between april 2009 and february 2018. Some or all of the esd procedures have been performed with unspecified olympus single use electrosurgical knife (dual knife), single use electrosurgical knife (dual knife j), and/or single use electrosurgical knife (it knife nano). Seven cases of postoperative bleedings and eight cases of intraoperative perforation were reportedly observed. The relationship between the subject devices and all of the reported complications could not been determined based on the available information. According to the number of the complications and the number of olympus devices which mighty have contributed to the complications, omsc is submitting forty-five medical device reports. This is a report on three of seven cases of postoperative bleeding regarding dual knife and three of forty-five reports.
 
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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 Key9669118
MDR Text Key190489868
Report Number8010047-2020-01100
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
Type of Report Initial
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received01/15/2020
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: 02/04/2020 Patient Sequence Number: 1
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