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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON: ANGIOTECH, PUERTO RICO, INC. UNDYED MONOFILAMENT; 16CMX16CM BIDIRECTIONAL TAPER POINT17MM
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ETHICON: ANGIOTECH, PUERTO RICO, INC. UNDYED MONOFILAMENT; 16CMX16CM BIDIRECTIONAL TAPER POINT17MM Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/05/2015
Event Type  malfunction  
Event Description
During surgery, ethicon stratafix needle disconnected from suture.Physician immediately aware and attempted to find needle.X-ray taken intraoperatively showed needle to be in sphincter muscle.Unable to safely retrieve needle.As of this date, no reports of patient problem reported.Additional needle also became disconnected from suture prior to use.Ethicon notified immediately the day of the occurrence.All needles/sutures with the lot number were removed from use and returned to ethicon.Ethicon was also reported this issue.Device unable to removed from patient.Comparable device and lot number in risk mgmt at hospital.
 
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Brand Name
UNDYED MONOFILAMENT
Type of Device
16CMX16CM BIDIRECTIONAL TAPER POINT17MM
Manufacturer (Section D)
ETHICON: ANGIOTECH, PUERTO RICO, INC.
MDR Report Key5508039
MDR Text Key40735507
Report Number5508039
Device Sequence Number2
Product Code GAN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/23/2016,02/02/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/05/2015
Event Location Hospital
Date Report to Manufacturer10/05/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/23/2016
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
Patient Weight79
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