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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN PI; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN PI; STAPLE, IMPLANTABLE Back to Search Results
Model Number 4901T
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 08/10/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Occupation: health professional (hpro).(surgical intervention).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during an open low anterior resection, on closure of the rectum, the instrument could be triggered correctly.The anastomosis was made with another circular stapler.The donuts of the circular stapler were complete.During the leak test, a leakage was detected.The surgeon overstitched the leakage to complete the case.
 
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Brand Name
PI
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key7826656
Report Number1219930-2018-04733
Device Sequence Number19211611
Product Code GDW
UDI-Device Identifier10884521066519
UDI-Public10884521066519
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K911252
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/29/2018
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 Number4901T
Device Catalogue Number4901T
Device Lot NumberN8B0228X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2018
Initial Report FDA Received Date08/29/2018
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 Required Intervention;
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