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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CELESTICA DE MONTERREY S.A. DE C.V. ENDO GIA; STAPLE, IMPLANTABLE
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CELESTICA DE MONTERREY S.A. DE C.V. ENDO GIA; STAPLE, IMPLANTABLE Back to Search Results
Model Number 030452
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/16/2020
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 laparoscopic wedge segmental resection procedure, the device fired, however there was "blue and y ellow fragments" break off from the reload.A new reload was used to resolve the issue.There was no patient injury.
 
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Brand Name
ENDO GIA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
CELESTICA DE MONTERREY S.A. DE C.V.
calle octava #102
parque industrial monterrey
apodaca nuevo leon
MX 
MDR Report Key11154776
Report Number3003139373-2021-00010
Device Sequence Number4116866
Product Code GDW
UDI-Device Identifier10884523002836
UDI-Public10884523002836
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K111825
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) 01/12/2021
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 Date04/16/2025
Device Model Number030452
Device Catalogue Number030452
Device Lot NumberT0D089X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/16/2020
Initial Report FDA Received Date01/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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