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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE Back to Search Results
Model Number 030412
Medical Device Problem Codes Misfire (2532); Failure to Form Staple (2579)
Health Effect - Clinical Code Unspecified Tissue Injury (4559)
Date of Event 12/13/2020
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, during a laparoscopic roux-en-y, while transecting the ileum, there was poor staple formation and the staple line was incomplete at the distal part.The staple line was fixed using another reload and suturing.
 
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Brand Name
ENDO GIA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key11148014
Report Number2647580-2021-00110
Device Sequence Number14361851
Product Code GDW
UDI-Device Identifier10884523002911
UDI-Public10884523002911
Combination Product (Y/N)N
Initial Reporter CountryEG
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/11/2021
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 Date05/31/2023
Device Model Number030412
Device Catalogue Number030412
Device Lot NumberP8E0908MX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/14/2020
Initial Report FDA Received Date01/11/2021
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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