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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP CLEARIFY LAPAROSCOPE, GENERAL PLASTIC SURGERY

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COVIDIEN LP CLEARIFY LAPAROSCOPE, GENERAL PLASTIC SURGERY Back to Search Results
Model Number 21-345
Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2019
Event Type  Malfunction  
Event Description

When using the trochar cleaner / swipe that comes in the covidien clearify visualization system, the foam tip detached and remained in the trochar. Luckily it was seen and removed immediately before instrumentation was inserted through the trochar. There are no rf or x-ray detectable strips on this foam. We will follow up with the care coordinator regarding the lot.

 
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Brand NameCLEARIFY
Type of DeviceLAPAROSCOPE, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key9391749
MDR Text Key168448721
Report Number9391749
Device Sequence Number1
Product Code GCJ
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 11/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number21-345
Device Catalogue Number21-345
Device LOT NumberP8J1606X
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/22/2019
Event Location Hospital
Date Report TO Manufacturer11/29/2019
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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