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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 Codes Entrapment of Device (1212); Failure to Fire (2610); Human-Device Interface Problem (2949)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
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, intra-operatively, the device would not release stapler.There was no patient injury.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key9530537
Report Number2647580-2019-06375
Device Sequence Number16246014
Product Code GDW
UDI-Device Identifier10884523003437
UDI-Public10884523003437
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/06/2020
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 Model Number030403
Device Catalogue Number030403
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/17/2019
Supplement Date Received by Manufacturer01/02/2020
Initial Report FDA Received Date12/30/2019
Supplement Report FDA Received Date01/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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