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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US ENDOSCOPY GROUP, INC. ROTH NET RETRIEVER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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US ENDOSCOPY GROUP, INC. ROTH NET RETRIEVER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number 00711170
Device Problem Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2020
Event Type  Malfunction  
Event Description

Roth net would not open. Fda safety report id# (b)(4).

 
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Brand NameROTH NET RETRIEVER
Type of DeviceLAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
US ENDOSCOPY GROUP, INC.
MDR Report Key9779982
MDR Text Key182215007
Report NumberMW5093484
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 02/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00711170
Device LOT Number1915049
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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