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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC. ESOPHYX Z+; ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)
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ENDOGASTRIC SOLUTIONS, INC. ESOPHYX Z+; ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) Back to Search Results
Model Number R2007
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2020
Event Type  malfunction  
Event Description
Endogastric solutions, inc.Esophyx z+ fastener delivery device with serosafuse fasteners malfunctioned and was unable to reload after first fire on patient.Once used on patient, the malfunctioned device was deemed unusable by sales representative and surgeons.The device was immediately removed from field.No harm occurred to patient during event and management was immediately notified.The device was placed in original packaging, and is to be reviewed by risk management.
 
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Brand Name
ESOPHYX Z+
Type of Device
ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Manufacturer (Section D)
ENDOGASTRIC SOLUTIONS, INC.
18109 ne 76th st
suite 100
redmond WA 98052
MDR Report Key10975521
MDR Text Key220456326
Report Number10975521
Device Sequence Number1
Product Code ODE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberR2007
Device Catalogue NumberR2007
Device Lot Number402864
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2020
Event Location Hospital
Date Report to Manufacturer12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age21900 DA
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