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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-611L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. Since the serial number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there is no description of the device's malfunction.
 
Event Description
On september 28, 2020, olympus medical systems corp. (omsc) received literature titled "feasibility of endoscopic submucosal dissection for upper gastrointestinal submucosal tumors treatment and value of endoscopic ultrasonography in pre-operation assess and postoperation follow-up: a prospective study of 224 cases in a single medical center". This study was conducted the endoscopic submucosal dissection (esd) for the upper gastrointestinal submucosal tumors on 224 patients between july 2011 and march 2015. The subject device, endoscope, transparent cap, forceps, needle, and endoclip were used during the procedure. In the literature, it was reported that complications of perforation, abdominal distension, chest tightness or subcutaneous emphysema, secondary peritonitis, massive bleeding have occurred. Thirteen of fourteen cases of the perforation were conservatively managed by medical therapy after applying endoscopic clips, with emergent operation needed in only one case. Five patients had massive bleeding during the procedure or postoperation, and three of them needed to receive emergent operation. There are no descriptions of device relevance for all adverse events in the literature. There is no description of the device's malfunction. Based on the available information, detailed information of the subject device was not provided. Whereas, omsc assumes that the perforation and the massive bleeding needed to receive emergency operation were related to the subject device due to occurred during the procedure. Therefore, omsc will submit two medical device report (mdr) for the perforation and the massive bleeding needed to receive emergency operation. This is the report regarding the perforation with emergent operation needed.
 
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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 Key10739909
MDR Text Key213187262
Report Number8010047-2020-08177
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-611L
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 Received09/28/2020
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

Patient Treatment Data
Date Received: 10/27/2020 Patient Sequence Number: 1
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