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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS Back to Search Results
Model Number FD-410LR
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Patient Problem Blood Loss (2597)
Event Date 03/29/2017
Event Type  malfunction  
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause could not be conclusively determined. A supplemental report will be submitted, if additional and significant information becomes available at a later time.
 
Event Description
During an endoscopic submucosal dissection, the doctor could not stop bleeding since the subject device was not activated. Therefore, the doctor stopped bleeding with another device and completed the intended procedure.
 
Manufacturer Narrative
This is a supplemental report for mfr report # 8010047-2017-00556 to provide additional information. The subject device was returned to olympus medical systems corp. (omsc) for evaluation. There were no defects on the subject device. The exact cause could not be conclusively determined. However, based on the similar cases in the past, it was known that failure of energization might occur because the current density decreased due to increasing of contact area between the tissue and the subject device. Also, the contact area between the tissue and the subject device might increase since the target tissue was soaked in water, the non-grasping section was come in contact with the tissue or the grasped tissue was too much. The instruction manual of the device has already warned as follows: pulling the tissue when applying the current. This could cause patient injury such as perforations and/or bleeding. When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure. Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.
 
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Brand NameSINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
Type of DeviceSINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 
426425177
MDR Report Key6553448
MDR Text Key248941107
Report Number8010047-2017-00556
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK062517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFD-410LR
Device Lot NumberK6Z280
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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