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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN AUTO SUTURE; BALLOON AND BLUNT TIP TROCAR
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COVIDIEN AUTO SUTURE; BALLOON AND BLUNT TIP TROCAR Back to Search Results
Catalog Number OMS-T10SB
Device Problems Break (1069); Inflation Problem (1310); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problem No Information (3190)
Event Date 01/19/2016
Event Type  malfunction  
Event Description
Had to open three structural balloons; the first one the sliding foam clip broke and the second one the balloon would not open.Chart reviewed.Procedural note: "the dissecting balloon was then withdrawn and a structural balloon was positioned.The initial structural balloon was difficult to inflate and the locking mechanism was faulty, so we discarded this and obtained a second unit, which would not inflate.Ultimately a third was inserted and inflated and then popped while placing our lower midline trocar and so a fourth was obtained and seated well.".
 
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Brand Name
AUTO SUTURE
Type of Device
BALLOON AND BLUNT TIP TROCAR
Manufacturer (Section D)
COVIDIEN
60 middletown avenue
north haven CT 06473
MDR Report Key5418597
MDR Text Key37725979
Report Number5418597
Device Sequence Number0
Product Code GCI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/02/2016,02/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2016
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Catalogue NumberOMS-T10SB
Device Lot NumberP5J0590X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/02/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Age48 YR
Patient Weight111
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