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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE
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COVIDIEN LP ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE Back to Search Results
Model Number 173016
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2017
Event Type  malfunction  
Event Description
An endo stitch suturing device was opened to the sterile field.As the surgeon went to use it during the case, it would not work properly.The device was removed from the field and a new device was successfully used.The procedure was completed as planned and no harm came to the patient.The device was sent to clinical engineering and upon further investigation, it appeared that the control buttons that pull the suture into the device were not evenly pushing down, therefore creating the potential for difficult manipulation by the surgeon.E-mailed photos.The device will be returned to the manufacturer for failure analysis.
 
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Brand Name
ENDO STITCH
Type of Device
ENDOSCOPIC TISSUE APPROXIMATION DEVICE
Manufacturer (Section D)
COVIDIEN LP
60 middletown ave.
north haven CT 06473
MDR Report Key6676434
MDR Text Key78673270
Report Number6676434
Device Sequence Number1
Product Code OCW
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
Report Date 06/26/2017,06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date02/28/2022
Device Model Number173016
Device Catalogue Number173016
Device Lot NumberJ7B2462X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/26/2017
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer06/26/2017
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
Patient Age45 YR
Patient Weight53
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