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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bowel Perforation (2668)
Event Type  Injury  
Event Description
Olympus medical systems corp. (omsc) received a literature titled "the value of endoscopic resection for non-ampullary duodenal lesions: a single-center experience". The literature reported the result of 84 patients with non-ampullary duodenal lesions who underwent endoscopic mucosal resection (emr) and endoscopic submucosal dissection (esd) procedure using olympus "dual knife or an insulation-tipped (it) nano knife" and other device. In the literature, the following complications have been reported to have occurred. Delayed bleeding (2 cases). Perforation (9 cases). Delayed perforation (1 case). The literature states as follows, "delayed bleeding was noted in 2 cases (2. 4%), which had undergone emr, both with tumors located in the descendant duodenum. Bleeding was controlled successfully with endoscopic electrocoagulation and hemoclipping. Perforation occurred during er in 9 cases(10. 7%), and all were closed immediately by hemoclips. As a result, all of these patients recovered non-operatively. One patient underwent delayed perforation and recovered non-operatively with total parenteral nutrition, gastrointestinal decompression, and intravenous antibiotics for 5 weeks. " there are not mentioned that these complications were related to the subject device in question. Based on the available information, specific information on the subject device and the patients were not provided. There is no description of the device's malfunction. However, omsc assumes that "delayed perforation" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury because the literature described that the event as "gastrointestinal decompression, and intravenous antibiotics for 5 weeks". Also, omsc determined that "delayed bleeding" and "perforation" are not serious events based on the descriptions in the literature. Therefore, omsc determined that the "delayed perforation" was adverse event to submit. Omsc will submit a medical device report (mdr) depending on the event.
 
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.
 
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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 Key13172838
MDR Text Key287672005
Report Number8010047-2022-00928
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 Other,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2022
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 Unkown

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
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