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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 GIA6038RL
Medical Device Problem Code Failure to Fire (2610)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/27/2018
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 esophagectomy, the device was applied at the anastomosis near neck to resect the stump however it did not fire.The black knob was able to move only till half and then the knob was stuck in between.Another reload was used to complete the case.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 Key7994856
Report Number1219930-2018-05625
Device Sequence Number1386691
Product Code GDW
UDI-Device Identifier20884521168616
UDI-Public20884521168616
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K122781
Number of Events Summarized1
Summary Report (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) 10/23/2018
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 Date01/31/2020
Device Model NumberGIA6038RL
Device Catalogue NumberGIA6038RL
Device Lot NumberN7A0586X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/28/2018
Initial Report FDA Received Date10/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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