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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 GIA6048S
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fistula (1862); No Code Available (3191)
Date of Event 05/12/2020
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, one day post-operatively on an exploratory laparoscopy surgery, the patient had fistula.The patient was re-operated to resolve the issue.
 
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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 Key10104054
Report Number2647580-2020-01678
Device Sequence Number19059478
Product Code GDW
UDI-Device Identifier10884523007244
UDI-Public10884523007244
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/01/2020
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 Date01/01/2021
Device Model NumberGIA6048S
Device Catalogue NumberGIA6048S
Device Lot NumberP6A0335KX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/14/2020
Initial Report FDA Received Date06/01/2020
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;
Patient Age59 YR
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