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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-640L
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2016
Event Type  Injury  
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 a per-oral endoscopic myotomy, the nurse found that the fluid was flowed back through the sheath of the subject device from the patient. Also, the nurse felt electrical stimulation three times on the handle of the subject device. The procedure was completed with the subject device. No injury except for electrical stimulation was reported.

 
Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2016-10126 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 tissue adhered on the cutting knife, the triangle tip and the slider of the subject device. As the result of checking the manufacturing record of the same lot, there was nothing abnormal found. Based on the evaluation and similar cased in the past, the nurse might feel electrical stimulation since high frequency flowed to the nurse through the tissue adhered on the slider. The tissue might adhere to the slider when the subject device was inserted to the endoscope or withdrawn from it. The instruction manual of the subject device already states; should the slightest irregularity be suspected, do not use the instrument or a cord; use a spare instead. Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforation, bleeding, mucous membrane damage or thermal injury and may result in more severe equipment damage.

 
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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
Manufacturer Contact
hiroki moriyama
2951 ishikawa-cho
hachioji-shi, tokyo-to 
8142642517
MDR Report Key6203822
MDR Text Key63259481
Report Number8010047-2016-10126
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberKD-640L
Device LOT NumberK6719
OTHER Device ID Number04953170208423
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/15/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/19/2016
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: 12/26/2016 Patient Sequence Number: 1
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