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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET; SNARE, FLEXIBLE
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UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET; SNARE, FLEXIBLE Back to Search Results
Catalog Number 00711052
Device Problems Bent (1059); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2016
Event Type  malfunction  
Event Description
During colonoscopy, the roth net was inserted into the olympus colonoscope in an attempt to deploy the basket.There was resistance felt.The wire at the handle bent immediately into what appears to be a normal qrs complex.Procedure completed as planned with no patient injury.
 
Event Description
During colonoscopy, the roth net was inserted into the olympus colonoscope in an attempt to deploy the basket.There was resistance felt.The wire at the handle bent immediately into what appears to be a normal qrs complex.Procedure completed as planned with no patient injury.
 
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Brand Name
ROTH NET
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley road
mentor OH 44060
MDR Report Key6193013
MDR Text Key62942323
Report Number6193013
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/13/2016,11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/01/2019
Device Catalogue Number00711052
Device Lot Number1604716
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/13/2016
Event Location Hospital
Date Report to Manufacturer09/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES; NO OTHER THERAPIES; OLYMPUS COLONOSCOPE; OLYMPUS COLONOSCOPE
Patient Age60 YR
Patient Weight73
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