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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN NEEDLE KNIFE V

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN NEEDLE KNIFE V Back to Search Results
Model Number KD-V441M
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event Description
During a procedure, the subject device was used.At the first output, the cutting knife of the subject device broke and fell.The fragment was retrieved.The intended procedure was completed with another device.There was no patient injury reported.
 
Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The fracture surface of the knife was melted and burnt.The length of the knife was measured.About 2 mm size of the knife was missing.The missing part was not returned.The outer diameter of the knife was measured.The result indicated no abnormalities.No other abnormalities were confirmed.  the manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that breakage of the knife was caused by the high temperature of the knife since discharge was generated due to the following factors during tissue incision.The output setting was high.The energizing time was long.The knife was not kept moving.The contact length between the tissue and the knife was short.The above device handling has warned in the instruction manual.
 
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Brand Name
SINGLE USE 3-LUMEN NEEDLE KNIFE V
Type of Device
SINGLE USE 3-LUMEN NEEDLE KNIFE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key11336351
MDR Text Key232805300
Report Number8010047-2021-02712
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K955247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberKD-V441M
Device Lot Number0XK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/29/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received03/09/2021
Supplement Dates FDA Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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