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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAPORT PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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DAVIS & GECK CARIBE LTD VERSAPORT PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 179095PF
Medical Device Problem Code Packaging Problem (3007)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/29/2016
Type of Reportable Event Malfunction
Event or Problem Description
According to the reporter, during a gastrectomy procedure the stabber of the trocar was broken and the knife was appeared.The problem noticed prior to use.There was no patient involvement.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
VERSAPORT PLUS
Common Device Name
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key6650181
Report Number9612501-2017-05644
Device Sequence Number1478095
Product Code GCJ
UDI-Device Identifier20884521081298
UDI-Public20884521081298
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K062326
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number179095PF
Device Catalogue Number179095PF
Device Lot NumberJ5K1675X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2016
Initial Date Received by Manufacturer 05/22/2017
Supplement Date Received by Manufacturer05/22/2017
Initial Report FDA Received Date06/19/2017
Supplement Report FDA Received Date10/04/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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