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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 GIA8038RL
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/02/2020
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, during firing of device on transverse colon in a hemicolectomy, one reload fired partially and the other reload got broken.The surgeon replaced the reload to resolve the issue.There was no patient injury.
 
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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 Key11076532
Report Number1219930-2020-05317
Device Sequence Number3206742
Product Code GDW
UDI-Device Identifier20884521168630
UDI-Public20884521168630
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K122781
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/28/2020
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 Expiration Date08/31/2021
Device Model NumberGIA8038RL
Device Catalogue NumberGIA8038RL
Device Lot NumberN8H0646X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/02/2020
Initial Report FDA Received Date12/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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