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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 B12STF
Device Problem Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2019
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 a laparoscopic gastroplasty, the membrane of scope retention mechanism broke. Another device was used to complete the case. There was no patient injury.

 
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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 Key9530406
MDR Text Key181558384
Report Number9612501-2019-02541
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK151548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
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 NumberB12STF
Device Catalogue NumberB12STF
Device LOT NumberJ8H1337X
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 Manufactured08/15/2018
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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