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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE Back to Search Results
Model Number SIGLU60A
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event 08/14/2021
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, hours after laparoscopic sleeve gastrectomy, patient had to be taken back to surgery for an additional hour procedure to control bleeding staple lines.Surgeon had to over sew the staple lines and a blood transfusion was required for the blood loss of more than 500 cc.Patient hospital stay was also extended for three days.
 
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Brand Name
SIGNIA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key12440566
Report Number1219930-2021-03704
Device Sequence Number3902285
Product Code GDW
UDI-Device Identifier10884521543508
UDI-Public10884521543508
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
K160176
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/08/2021
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 NumberSIGLU60A
Device Catalogue NumberSIGLU60A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/21/2021
Initial Report FDA Received Date09/08/2021
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 Hospitalization; Required Intervention;
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