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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 Failure to Form Staple (2579)
Health Effect - Clinical Codes Failure to Anastomose (1028); No Code Available (3191)
Date of Event 10/31/2019
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 right hemicolectomy, after the device was fired at the third firing (side-to-side anastomosis), when the anastomosed site was checked, it was found to be not anastomosed successfully and the staples were not formed to be u-shape.Manual suturing was performed to recover the staple line, and on the entry hole without using device.
 
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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 Key9335252
Report Number1219930-2019-06419
Device Sequence Number1849339
Product Code GDW
UDI-Device Identifier20884521168630
UDI-Public20884521168630
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K122781
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/18/2019
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 Date01/31/2022
Device Model NumberGIA8038RL
Device Catalogue NumberGIA8038RL
Device Lot NumberN9B0135Y
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/31/2019
Initial Report FDA Received Date11/18/2019
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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