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ETHICON SECURESTRAP OPENSTRAP20Recalls & reported problems

Ethicon, LLC · Absorbable Strap Fixation Device · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031202757), received between May 14, 2018 and Apr 9, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Failure To Adhere Or Bond1
  • Loss of or Failure to Bond1

Patient problems

  • No Consequences Or Impact To Patient2
  • Blood Loss1
  • Not Applicable1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

    IT WAS REPORTED THAT A PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE IN 2020 AND THE ABSORBABLE STRAPS WERE USED. IT WAS REPORTED THAT THE HANDLE WAS STUCK IN AND THE OPERATING ROOM STAFF WAS ABLE TO GET IT UNSTUCK. IT WAS ALSO REPORTED THAT AFTER GETTING THE DEVICE UNSTUCK, THE DEVICE WAS FIRING VERY ROUGH AND NOT TACKING PROPERLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9947479 ↗
  • InjuryJan 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND THE ABSORBABLE STRAPS WERE USED. IT WAS REPORTED THAT THE SHARP TRACKER EDGES CAUSED PATIENT BLEEDING FROM THE FIXATION POINT, AND THE SURGEON HAD TO RE-OPERATE THE PATIENT.

    Patient problems: Blood Loss; Not Applicable

    MAUDE report 9604702 ↗
  • MalfunctionMay 14, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED USING THE IPOM TECHNIQUE. DURING THE PROCEDURE, MULTIPLE STRAPS FELL OFF AND WOULD NOT FIX. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE AND NO PATIENT CONSEQUENCES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7511320 ↗

Other STAPLE, IMPLANTABLE devices

All STAPLE, IMPLANTABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.