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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ILA; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN ILA; STAPLE, IMPLANTABLE Back to Search Results
Model Number 3975
Medical Device Problem Codes Failure to Cut (2587); Material Twisted/Bent (2981)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during a during functional end-to-end anastomosis in transverse colectomy.The defect occurred when closing the common hole after side-by-side anastomosis.At the first firing, while grasping the tissue and proceeding the firing, it became hard from the halfway and the knife bar became bent although the firing advanced to the end.When observing the tissue after releasing the device, it was found that the staples were applied, but the cutting was only half way done.The tissue that was not separated completely was cut with an electrosurgical knife and reinforced with the needle and thread, and the operation was completed.
 
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Brand Name
ILA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key8263234
Report Number1219930-2019-00414
Device Sequence Number16506018
Product Code GDW
UDI-Device Identifier10884521064614
UDI-Public10884521064614
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K885222
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) 01/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number3975
Device Catalogue Number3975
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/25/2018
Initial Report FDA Received Date01/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
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