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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSASTEP PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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DAVIS & GECK CARIBE LTD VERSASTEP PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number VS101512P
Medical Device Problem Code Packaging Problem (3007)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/03/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, intra operatively, half of a pea sized plastic was broke off at the distal end of the device.It was reported broken piece was found barely attached to the outside of the device after use.
 
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Brand Name
VERSASTEP 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 Key8289169
Report Number9612501-2019-00159
Device Sequence Number16679660
Product Code GCJ
UDI-Device Identifier10884521082854
UDI-Public10884521082854
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K012539
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/30/2019
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 Expiration Date07/31/2023
Device Model NumberVS101512P
Device Catalogue NumberVS101512P
Device Lot NumberJ8G0643X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/07/2019
Initial Report FDA Received Date01/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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