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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE

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COVIDIEN ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE Back to Search Results
Model Number 10MM
Device Problems Difficult to Insert (1316); Difficult to Open or Close (2921)
Patient Problem No Information (3190)
Event Date 02/14/2017
Event Type  malfunction  
Event Description
Device failed during use, the mouth of auto suture device that holds suture would not open, unable to load suture, removed stapler form the field and new stapler obtained for use.
 
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Brand NameENDO STITCH
Type of DeviceENDOSCOPIC TISSUE APPROXIMATION DEVICE
Manufacturer (Section D)
COVIDIEN
60 middletown ave.
north haven CT 06473
MDR Report Key6390864
MDR Text Key69458351
Report Number6390864
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10MM
Device Catalogue Number173016
Device Lot NumberJ6L2470X
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2017
Event Location Other
Date Report to Manufacturer03/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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