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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE
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OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE Back to Search Results
Model Number SD-210U-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Electric Shock (2554)
Event Date 06/28/2021
Event Type  Injury  
Manufacturer Narrative
The subject device referenced in this report has not yet been returned to 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
Olympus medical systems corp. (omsc) was informed by the nurse that during an endoscopic mucosal resection using the subject device, the doctor used the yellow pedal, which omsc estimated that is the switch of vio3 erbe, to take off a polyp. The patient jerked immediately and said she felt like an electric shock. The doctor finished cutting off the polyp. Then, they changed the snare from 15mm to a 10mm olympus snare because they took off another polyp. The nurse thought that the snares might be at fault. The engineer from erbe came the next day after the incident and found no fault with the machine. The patient was re-admitted after the procedure due to a post polypectomy bleeding, but the nurse said it was not due to this incident as the patient had a lot of polyps removed.
 
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Brand NameDISPOSABLE ELECTROSURGICAL SNARE
Type of DeviceDISPOSABLE ELECTROSURGICAL SNARE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key12230158
MDR Text Key263607864
Report Number8010047-2021-09379
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K902735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberSD-210U-15
Device Lot NumberV04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/27/2021 Patient Sequence Number: 1
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