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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-620

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-620 Back to Search Results
Model Number KD-620QR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc). The exact cause has been under investigation. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event Description
The following events were reported in the endoscopica digestiva vol. 30 no. 4 2018. Article title: techniques for safely performing duodenal esd. Summary: kd-650q and/or kd-620qr were used in the study of treatment outcome comparing the pocket-creation method (pcm group) and conventional endoscopic submucosal dissection (conventional method: cm group). The total cases were 45 which were performed from 2006 to 2015. In the study, accidental symptoms occurred as follows. The number of accidental symptoms were calculated by multiplying the total cases by the incidence rate. - pcm group: perforation 7% (2 cases), postoperative bleeding 4% (1 case), - cm group: perforation 29% (5 cases), postoperative perforation 6% (1 case), emergency operation 6% (1 case), postoperative bleeding 18% (3 cases), the malfunction of the subject device has not been reported. This report is regarding kd-620qr, cm group, postoperative bleeding 3 of 3 cases.
 
Manufacturer Narrative
This is a supplemental report to provide additional information. The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, omsc could not evaluate the reported device. The exact cause of this issue could not be conclusively determined. However, omsc has only shipped devices which passed the inspection. From the reported information, it is assumed that the event did not occur due to malfunction of the device, but occurred as a general accidental symptom of the procedure.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE KD-620
Type of DeviceSINGLE USE ELECTROSURGICAL KNIFE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7521631
MDR Text Key108503911
Report Number8010047-2018-00876
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature,user facility
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-620QR
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/04/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/17/2018 Patient Sequence Number: 1
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