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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN VISPRT PLUS 11MM OBTR + 5MM-12MM SEAL RT; DISPOSABLE SURGICAL ACCESS DEVICE
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COVIDIEN VISPRT PLUS 11MM OBTR + 5MM-12MM SEAL RT; DISPOSABLE SURGICAL ACCESS DEVICE Back to Search Results
Catalog Number 176773P
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2014
Event Type  malfunction  
Event Description
Procedure: lap nissen.According to the reporter: while the surgeon assembled the trocar by putting the visiport in the cannula, the visiport broke.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
VISPRT PLUS 11MM OBTR + 5MM-12MM SEAL RT
Type of Device
DISPOSABLE SURGICAL ACCESS DEVICE
Manufacturer (Section D)
COVIDIEN
zona franca de san isidro
santo domingo
DR 
Manufacturer (Section G)
COVIDIEN
zona franca de san isidro
carretara san isidro km17
santo domingo
DR  
Manufacturer Contact
shraon murphy, qa
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key4041918
MDR Text Key4909164
Report Number9612501-2014-00261
Device Sequence Number1
Product Code GDT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K963115
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/30/2019
Device Catalogue Number176773P
Device Lot NumberJ4A2055X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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