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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 Misfire (2532)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/22/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the event occurred before the first firing in laparo hepatectomy.Even though the surgeon tried stapling, there was a possibility that adaptive firing technology operated due to the thickness of the tissue and the stapling stopped.The firing stopped halfway.New reload was used for the same tissue and the stapling was completed without problems.The status of the patient was reported as no problem.
 
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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 Key8073220
Report Number1219930-2018-06080
Device Sequence Number244544
Product Code GDW
UDI-Device Identifier10884521510579
UDI-Public10884521510579
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K121510
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/15/2018
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 10/23/2018
Initial Report FDA Received Date11/15/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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