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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-645

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-645 Back to Search Results
Model Number KD-645L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 09/27/2018
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) since it was discarded. 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
During a per-oral endoscopic myotomy, the subject device was used. The doctor thinks that the knife length was longer than it suppose to. The procedure was completed. A bleeding occurred after the procedure. A pleura drainage was placed in the patient to remove the blood. The patient was fully recovered.
 
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, the exact cause of the reported event could not be conclusively determined. The lot number of the subject device is unknown. As a result of checking the manufacturing record for past one year from the delivery date, it was found no irregularities. Based on the past similar events, it is assumed that the bleeding occurred due to the following causes. The tissue was cut too deeply. The thick vessel was damaged. The instruction manual of the device has already warned as follows; do not resect tissue too deep. Deep resection of tissue may cause bleeding,perforation, pneumomediastinum, and/or aerodermectasia during or after the procedure. When resecting tissue, confirm that there is no irregularity in there secting area and monitor the patient¿s condition all the time. Do not angulate the bending section of the endoscope abruptly while the distal end of the insertion portion is extended from the distal end of the endoscope. This could cause patient injury, such as perforation, bleeding, or tissue damage.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE KD-645
Type of DeviceSINGLE USE ELECTROSURGICAL KNIFE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key8040920
MDR Text Key126217112
Report Number8010047-2018-02132
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-645L
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/06/2018 Patient Sequence Number: 1
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