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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAPORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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DAVIS & GECK CARIBE LTD VERSAPORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number NB5STF
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, pre-operatively, the product¿s packaging was received as damaged.It was stated that the seal of the device was also damaged.The malfunction occurred on two devices.There was no patient involvement.
 
Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that there was a large rip in the packaging spanning from the area of the pull tab and creating a half moon shape.The seal around the packaging remained intact.Functionally, the device passed an air leak test.It was reported that there was damage to a seal in the device, and the packaging of a device appeared to be different than expected.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
VERSAPORT
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DR  0101
MDR Report Key12159701
MDR Text Key261296786
Report Number9612501-2021-01151
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10884521076747
UDI-Public10884521076747
Combination Product (y/n)N
PMA/PMN Number
K100548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNB5STF
Device Catalogue NumberNB5STF
Device Lot NumberJ1B1810Y
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2021
Date Manufacturer Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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