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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN VERSASTEP PLUS LAPAROSCOPE, GENERAL PLASTIC SURGERY

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COVIDIEN VERSASTEP PLUS LAPAROSCOPE, GENERAL PLASTIC SURGERY Back to Search Results
Model Number VS101015P
Device Problems Seal (432); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2019
Event Type  Malfunction  
Event Description

Seal came off in patient's abdomen - seal was removed from patient. Manufacturer response for 15mm verastep, versastep (per site reporter). No response from manufacturer.

 
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Brand NameVERSASTEP PLUS
Type of DeviceLAPAROSCOPE, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN
60 middletown ave
north haven CT 06473
MDR Report Key9877812
MDR Text Key184874911
Report Number9877812
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 02/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVS101015P
Device Catalogue NumberVS101015P
Device LOT NumberJ9B1738Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/26/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2020
Event Location Hospital
Date Report TO Manufacturer03/25/2020
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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