VERSASTEP VS101005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for VERSASTEP VS101005 manufactured by Covidien.

Event Text Entries

[184856601] All 3 trocars were sticking. Whenever a 5mm device was inserted in the trocar it would be difficult to insert or remove the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9877760
MDR Report Key9877760
Date Received2020-03-25
Date of Report2020-02-24
Date of Event2018-09-28
Report Date2020-02-24
Date Reported to FDA2020-02-24
Date Reported to Mfgr2020-03-25
Date Added to Maude2020-03-25
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERSASTEP
Generic NameLAPAROSCOPE, GENERAL PLASTIC SURGERY
Product CodeGCJ
Date Received2020-03-25
Returned To Mfg2018-10-08
Model NumberVS101005
Catalog NumberVS101005
Lot NumberJ8E2124X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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