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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 VS100712P
Device Problem Packaging Problem (3007)
Patient Problem No Information (3190)
Event Date 11/01/2019
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during appendectomy, the tip of 12mm trocar cracked upon attempt to remove appendix through trocar. Cracked pieces remained attached to trocar.

 
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Brand NameVERSASTEP PLUS
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO 0101
Manufacturer (Section G)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO 0101
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key9532142
MDR Text Key178351582
Report Number9612501-2019-02546
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK012539
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 12/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVS100712P
Device Catalogue NumberVS100712P
Device LOT NumberJ9E1804Y
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/15/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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