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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO GIA; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO GIA; STAPLE, IMPLANTABLE Back to Search Results
Model Number 030403
Medical Device Problem Code Difficult to Open or Close (2921)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/15/2019
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 a hand assisted laparoscopic colectomy, that a reload was used and was noted that they are not sure whether it's the purple or tan reload that would not close or fire.A new handle of the same model was used to complete the case.There was no patient injury.
 
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Brand Name
GIA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key8748057
Report Number2647580-2019-03417
Device Sequence Number1668372
Product Code GDW
UDI-Device Identifier20884523003434
UDI-Public20884523003434
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/01/2019
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 Date08/31/2023
Device Model Number030403
Device Catalogue Number030403
Device Lot NumberP8H1544X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/11/2019
Initial Report FDA Received Date07/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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