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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 NONB15STF
Device Problems Seal (432); Break (1069); Detachment of Device or Device Component (2907); Gas Leak (2946); Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2018
Event Type  Malfunction  
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 a laparoscopic sleeve gastrectomy, on access, the device had a damaged and disengaged seal. There was air or gas leaked from the seal. There was no patient injury.

 
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 Key7718660
MDR Text Key115191205
Report Number9612501-2018-01353
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK160230
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
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNONB15STF
Device Catalogue NumberNONB15STF
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
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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