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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN IDRIVE ULTRA; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN IDRIVE ULTRA; STAPLE, IMPLANTABLE Back to Search Results
Model Number IDRVULTRA2
Medical Device Problem Code Failure to Fire (2610)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/07/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during lobectomy pulmonary vasculature, the reload placed on tissue and closed it but the surgeon was unable to press the green button and the device did not fire.This happened with the second black reload.A new handle and reload was used to complete the case.There was no patient injury.
 
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Brand Name
IDRIVE ULTRA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key7812929
Report Number1219930-2018-04660
Device Sequence Number221601
Product Code GDW
UDI-Device Identifier10884521510579
UDI-Public10884521510579
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K121510
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/24/2018
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
Operator of Device Health Professional
Device Model NumberIDRVULTRA2
Device Catalogue NumberIDRVULTRA2
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/07/2018
Initial Report FDA Received Date08/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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