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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAONE LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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DAVIS & GECK CARIBE LTD VERSAONE LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number NONB12STF
Device Problems Seal (432); Break (1069); Leak/Splash (1354); Gas Leak (2946); Packaging Problem (3007)
Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)
Event Date 06/21/2018
Event Type  Injury  
Manufacturer Narrative

¿occupation: health professional (hpro)¿. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during retroperitoneal nephrectomy, there was a bleeding out of the nephro. The surgeon has to remove the bleeding with vacuum; however, they have no space to see anything because of the leaked trocar. There was a damaged seal and air/gas leaked from the seal. A new trocar was used to complete the case. There was blood loss more than 500 cc due to the product problem.

 
Manufacturer Narrative

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

 
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Brand NameVERSAONE
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 Key7719921
MDR Text Key115030160
Report Number9612501-2018-01357
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK151548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNONB12STF
Device Catalogue NumberNONB12STF
Device LOT NumberJ8A2268X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/30/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/25/2018 Patient Sequence Number: 1
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