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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 Problem Bowel Perforation (2668)
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
Olympus medical systems corp. (omsc) received a literature titled "hybrid endoscopic submucosal dissection: an alternative resection modality for large laterally spreading tumors in the cecum?". The literature reported the result of 62 patients with large laterally spreading tumors in the cecum who underwent hybrid endoscopic submucosal dissection (esd) procedure using olympus dual or it knife and non olympus polypectomy snare between january of 2008 and june of 2019. In the literature, it was reported complication as follows; (1) post-procedure bleeding (1case): it was described in the literature as follows. " one patient with post-procedure bleeding was successfully treated with endoscopic hemostasis therapy. " (2) perforation (1case): it was described in the literature as follows. " one patient perforated during the esd procedure, which was surgically treated. " (3) post-procedure abdominal pain and fever (11 cases) (4) additional surgery (3cases): it was described in the clinical outcomes of the literature as follows. "two patients in the esd group and one patient in the hybrid esd group underwent additional surgery. " (5) recurrence (1case). 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 "perforation" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury. Omsc also assumed that "additional surgery" was not related to the subject device because it was not described under "complication" in the literature, but as a "clinical outcome". Therefore, omsc determined that the "perforation" was adverse event to submit. Omsc will submit a medical device report (mdr) depending on the event.
 
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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 Key12538201
MDR Text Key273623573
Report Number8010047-2021-12357
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,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
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? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2022
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 Initial

Patient Treatment Data
Date Received: 09/27/2021 Patient Sequence Number: 1
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