Elastic Staples ES-10x10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842188108952), received between Oct 18, 2018 and Jul 10, 2020 — classified as 7 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018 IT WAS REPORTED TO TRIMED THAT THERE WAS A INCIDENT OF INFECTION RELATED TO A SURGERY THAT INVOLVED THE TRIMED NITINOL STAPLE. ON (B)(6) TRIMED WAS GIVEN MORE INFORMATION ON THE INCIDENT, AND THAT THERE WERE SEVEN STAPLES INVOLVED IN THE ONE INCIDENT OF INFECTION. THERE WERE A TOTAL OF SEVEN STAPLES INVOLVED FROM LOTS 317003 (QUANTITY 3) AND LOT 317004 (QUANTITY 4). THIS INCIDENT WAS DISCOVERED AT (B)(6) HOSPITAL IN (B)(6). AN ACTIVE INFECTION WAS DISCOVERED NEAR THE SURGICAL SITE WITHIN THE FIRST POST-OPERATIVE WEEK. THIS IS THE FIRST TIME THIS TYPE OF INCIDENT HAS BEEN REPORTED TO TRIMED WITH THE CONCOMITANT USE OF THE NITINOL STAPLE.

  Patient problems: Unspecified Infection

  MAUDE report 7982437 ↗
• InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON MAY 8TH, 2018 IT WAS REPORTED TO TRIMED THAT THERE WAS A INCIDENT OF INFECTION RELATED TO A SURGERY THAT INVOLVED THE TRIMED NITINOL STAPLE. ON MAY 13TH, TRIMED WAS GIVEN MORE INFORMATION ON THE INCIDENT, AND THAT THERE WERE SEVEN STAPLES INVOLVED IN THE ONE INCIDENT OF INFECTION. THERE WERE A TOTAL OF SEVEN STAPLES INVOLVED FROM LOTS 317003 (QUANTITY 3) AND LOT 317004 (QUANTITY 4). THIS INCIDENT WAS DISCOVERED AT (B)(6) HOSPITAL IN (B)(6). AN ACTIVE INFECTION WAS DISCOVERED NEAR THE SURGICAL SITE WITHIN THE FIRST POST-OPERATIVE WEEK. THIS IS THE FIRST TIME THIS TYPE OF INCIDENT HAS BEEN REPORTED TO TRIMED WITH THE CONCOMITANT USE OF THE NITINOL STAPLE.

  Patient problems: Unspecified Infection

  MAUDE report 7982439 ↗
• InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018 IT WAS REPORTED TO TRIMED THAT THERE WAS A INCIDENT OF INFECTION RELATED TO A SURGERY THAT INVOLVED THE TRIMED NITINOL STAPLE. ON MAY 13TH, TRIMED WAS GIVEN MORE INFORMATION ON THE INCIDENT, AND THAT THERE WERE SEVEN STAPLES INVOLVED IN THE ONE INCIDENT OF INFECTION. THERE WERE A TOTAL OF SEVEN STAPLES INVOLVED FROM LOTS 317003 (QUANTITY 3) AND LOT 317004 (QUANTITY 4). THIS INCIDENT WAS DISCOVERED AT (B)(6) HOSPITAL IN (B)(6). AN ACTIVE INFECTION WAS DISCOVERED NEAR THE SURGICAL SITE WITHIN THE FIRST POST-OPERATIVE WEEK. THIS IS THE FIRST TIME THIS TYPE OF INCIDENT HAS BEEN REPORTED TO TRIMED WITH THE CONCOMITANT USE OF THE NITINOL STAPLE.

  Patient problems: Unspecified Infection

  MAUDE report 7982438 ↗
• InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018 IT WAS REPORTED TO TRIMED THAT THERE WAS A INCIDENT OF INFECTION RELATED TO A SURGERY THAT INVOLVED THE TRIMED NITINOL STAPLE. ON MAY 13TH, TRIMED WAS GIVEN MORE INFORMATION ON THE INCIDENT, AND THAT THERE WERE SEVEN STAPLES INVOLVED IN THE ONE INCIDENT OF INFECTION. THERE WERE A TOTAL OF SEVEN STAPLES INVOLVED FROM LOTS 317003 (QUANTITY 3) AND LOT 317004 (QUANTITY 4). THIS INCIDENT WAS DISCOVERED AT (B)(6) HOSPITAL IN (B)(6). AN ACTIVE INFECTION WAS DISCOVERED NEAR THE SURGICAL SITE WITHIN THE FIRST POST-OPERATIVE WEEK. THIS IS THE FIRST TIME THIS TYPE OF INCIDENT HAS BEEN REPORTED TO TRIMED WITH THE CONCOMITANT USE OF THE NITINOL STAPLE.

  Patient problems: Unspecified Infection

  MAUDE report 7982436 ↗
• InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018 IT WAS REPORTED TO TRIMED THAT THERE WAS A INCIDENT OF INFECTION RELATED TO A SURGERY THAT INVOLVED THE TRIMED NITINOL STAPLE. ON MAY 13TH, TRIMED WAS GIVEN MORE INFORMATION ON THE INCIDENT, AND THAT THERE WERE SEVEN STAPLES INVOLVED IN THE ONE INCIDENT OF INFECTION. THERE WERE A TOTAL OF SEVEN STAPLES INVOLVED FROM LOTS 317003 (QUANTITY 3) AND LOT 317004 (QUANTITY 4). THIS INCIDENT WAS DISCOVERED AT (B)(6) HOSPITAL IN (B)(6). AN ACTIVE INFECTION WAS DISCOVERED NEAR THE SURGICAL SITE WITHIN THE FIRST POST-OPERATIVE WEEK. THIS IS THE FIRST TIME THIS TYPE OF INCIDENT HAS BEEN REPORTED TO TRIMED WITH THE CONCOMITANT USE OF THE NITINOL STAPLE.

  Patient problems: Unspecified Infection

  MAUDE report 7982435 ↗
• InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON MAY 8TH, 2018 IT WAS REPORTED TO TRIMED THAT THERE WAS A INCIDENT OF INFECTION RELATED TO A SURGERY THAT INVOLVED THE TRIMED NITINOL STAPLE. ON MAY 13TH, TRIMED WAS GIVEN MORE INFORMATION ON THE INCIDENT, AND THAT THERE WERE SEVEN STAPLES INVOLVED IN THE ONE INCIDENT OF INFECTION. THERE WERE A TOTAL OF SEVEN STAPLES INVOLVED FROM LOTS 317003 (QUANTITY 3) AND LOT 317004 (QUANTITY 4). THIS INCIDENT WAS DISCOVERED AT (B)(6) HOSPITAL IN (B)(6). AN ACTIVE INFECTION WAS DISCOVERED NEAR THE SURGICAL SITE WITHIN THE FIRST POST-OPERATIVE WEEK. THIS IS THE FIRST TIME THIS TYPE OF INCIDENT HAS BEEN REPORTED TO TRIMED WITH THE CONCOMITANT USE OF THE NITINOL STAPLE.

  Patient problems: Unspecified Infection

  MAUDE report 7982434 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON MAY 8TH, 2018 IT WAS REPORTED TO TRIMED THAT THERE WAS A INCIDENT OF INFECTION RELATED TO A SURGERY THAT INVOLVED THE TRIMED NITINOL STAPLE. ON MAY 13TH, TRIMED WAS GIVEN MORE INFORMATION ON THE INCIDENT, AND THAT THERE WERE SEVEN STAPLES INVOLVED IN THE ONE INCIDENT OF INFECTION. THERE WERE A TOTAL OF SEVEN STAPLES INVOLVED FROM LOTS 317003 (QUANTITY 3) AND LOT 317004 (QUANTITY 4). THIS INCIDENT WAS DISCOVERED AT (B)(6) HOSPITAL IN AUSTRALIA. AN ACTIVE INFECTION WAS DISCOVERED NEAR THE SURGICAL SITE WITHIN THE FIRST POST-OPERATIVE WEEK. THIS IS THE FIRST TIME THIS TYPE OF INCIDENT HAS BEEN REPORTED TO TRIMED WITH THE CONCOMITANT USE OF THE NITINOL STAPLE.

  Patient problems: Unspecified Infection

  MAUDE report 7982432 ↗