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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACEMAKER PLUS COVIDIEN SPACEMAKER
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SPACEMAKER PLUS COVIDIEN SPACEMAKER Back to Search Results
Model Number SMBTTOVL
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2017
Event Type  malfunction  
Event Description
Surgeon was doing a lab hernia.Upon opening the package, the trocar had a piece of the gasket missing.Surgeon believed there may have been an issue with the seal.No harm was done to the patient or staff, surgeon believed it was a manufacture error.
 
Event Description
Surgeon was doing a lab hernia.Upon opening the package, the trocar had a piece of the gasket missing.Surgeon believed there may have been an issue with the seal.No harm was done to the patient or staff, surgeon believed it was a manufacture error.
 
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Brand Name
COVIDIEN SPACEMAKER
Type of Device
COVIDIEN SPACEMAKER
Manufacturer (Section D)
SPACEMAKER PLUS
555 long wharf drive
new haven CT 06511
MDR Report Key7134342
MDR Text Key95489240
Report Number7134342
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 11/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/30/2019
Device Model NumberSMBTTOVL
Device Catalogue NumberSMBTTOVL
Device Lot NumberP7F 0664X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/02/2017
Event Location Hospital
Date Report to Manufacturer11/02/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/20/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age69 YR
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