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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP ENDO CLIP II; CLIP, IMPLANTABLE
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COVIDIEN LP ENDO CLIP II; CLIP, IMPLANTABLE Back to Search Results
Model Number 176657
Device Problem Misfire (2532)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
The clip applier misfired during surgery.
 
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Brand Name
ENDO CLIP II
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key13756998
MDR Text Key287111925
Report Number13756998
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/08/2022,02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number176657
Device Catalogue Number176657
Device Lot NumberJ1C29949NY
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/08/2022
Event Location Hospital
Date Report to Manufacturer03/14/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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