Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO TA; STAPLE, IMPLANTABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

US SURGICAL PUERTO RICO TA; STAPLE, IMPLANTABLE Back to Search Results
Model Number TA9048L
Medical Device Problem Codes Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/20/2020
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 an open esophagus resection, there was a poor staple formation.The staples were not formed correctly.They were not closed.The staple line was incomplete.They reloaded the stapler, but the second staple line was also incomplete and the staples were malformed.Staples fell into the cavity and were all retrieved.They oversew to fix the staple line.The procedure was extended by one hour more.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key9656927
Report Number2647580-2020-00428
Device Sequence Number355534
Product Code GDW
UDI-Device Identifier10884521043268
UDI-Public10884521043268
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (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) 02/02/2020
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 Model NumberTA9048L
Device Catalogue NumberTA9048L
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/20/2020
Initial Report FDA Received Date02/02/2020
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;
-
-