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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIAMAX; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN RELIAMAX; STAPLE, IMPLANTABLE Back to Search Results
Model Number GIA8048RL
Medical Device Problem Code Failure to Form Staple (2579)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 08/29/2018
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 an open triple bypass and specimen was taken from the pancreatic head, there was a poor staple formation and bleeding from the staple line.The staple line was fixed thru over sewing in order to resolve the issue in order to complete the case.The surgical time was extended by more than 30 minutes.
 
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Brand Name
RELIAMAX
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key7902242
Report Number1219930-2018-05178
Device Sequence Number18887579
Product Code GDW
UDI-Device Identifier20884521168647
UDI-Public20884521168647
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K122781
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/24/2018
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 Expiration Date02/29/2020
Device Model NumberGIA8048RL
Device Catalogue NumberGIA8048RL
Device Lot NumberN7B0865X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/31/2018
Initial Report FDA Received Date09/24/2018
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 Other; Required Intervention;
Patient Age59 YR
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