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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 Problems Seal (432); Break (1069); Leak/Splash (1354); 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 06/20/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, at the beginning of a laparoscopic gastric bypass revision, the seal was damaged and air was leaking from it. They had to use another cannula but it also failed at the middle of the procedure. They replaced these with another same device to finish the case. There was no patient injury.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device. The visual inspection of the returned photo noted: the photo depicts the device inside a blister pack. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition. 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 Key7671460
MDR Text Key113750434
Report Number9612501-2018-01263
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2018
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 NumberJ7E0793X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2017
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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