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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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp (omsc) for evaluation.Since the lot no.Is unknown, the manufacturing history record (dhr) could not be reviewed.However, omsc has only shipped devices which passed the inspection.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined because the subject device was not returned omsc for evaluation.
 
Event Description
On february 13th, 2020, olympus medical systems corp.(omsc) received a literature titled ¿impact of electrical pulse cut mode during endoscopic papillectomy:pilot randomized clinical trial¿.The literature reported results of the sixty procedures of endoscopic papillectomy using an olympus disposable electrosurgical snare between april 2016 and april 2018.Nine cases of procedure-related delayed bleeding were reportedly observed.The delayed bleedings were stopped using a non-olympus hemoclip (resolution, boston scientific (b)(4)).The relationship between the subject device and all of the reported complications could not been determined based on the available information.According to the number of the complications and the number of olympus device which mighty have contributed to the complications, omsc is submitting nine medical device reports.This is one of nine reports.
 
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Brand Name
DISPOSABLE ELECTROSURGICAL SNARE
Type of Device
DISPOSABLE 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 Key9821858
MDR Text Key194346023
Report Number8010047-2020-01754
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/13/2020
Initial Date FDA Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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