ETHICON SECURESTRAP OPSTRAP20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031231054), received between Jul 14, 2022 and Nov 28, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (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

Recent adverse event reports

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

• MalfunctionNov 28, 2025Firing Problem

  DURING THE SURGERY, THE SECURESTRAP WAS NOT FIRING AND IT WAS TAKEN OUT OF USE, AND ANOTHER DEVICE WAS USED. THERE WAS NOT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671403 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: PERIOPERATIVE AND 5-YEAR FOLLOW-UP OUTCOMES INTRAOPERATIVE COMPLICATIONS - TOTAL 37 - BLEEDING 18, ORGAN INJURIES 27, VASCULAR 9, BOWEL 14, BLADDER 2, STOMACH 0, SPLEEN 1, LIVER 0, OTHERS 1. GENERAL COMPLICATIONS - TOTAL 43 - FEVER 1, URINARY TRACT INFECTION 5, DIARRHEA 3, GASTRITIS 1, THROMBOSIS 2, PULMONARY EMBOLISM 2, PLEURAL EFFUSION 2, PNEUMONIA 7, COPD 4, CARDIAC INSUFFICIENCY 4, CORONARY HEARTH DISEASE 1, MYOCARDIAL INFARCTION 1, RENAL INSUFFICIENCY 3, HYPERTENSIVE CRISIS 2, PATIENT DECEASED 0, OTHERS 15. POSTOPERATIVE COMPLICATIONS - TOTAL 54 - BLEEDING 14, SEROMA 26, PROLONGED ILEUS OR OBSTRUCTION 5, BOWEL INJURY/ANASTOMOTIC INSUFFICIENCY 3, WOUND HEALING DISORDER 5, INFECTION 4. COMPLICATION-RELATED REOPERATIONS TOTAL 16. RECURRENCE, PAIN AND COMPLICATIONS ON 5-YEAR FOLLOW-UP - RECURRENCE 158 - PAIN ON EXERTION 190, PAIN AT REST 89, PAIN REQUIRING TREATMENT 69, TROCAR HERNIA 5, SECO

  Patient problems: Diarrhea; Fever; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Myocardial Infarction; Obstruction/Occlusion; Pain; Perforation of Vessels; Pleural Effusion; Pneumonia; Pulmonary Embolism; Seroma; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 15839420 ↗
• MalfunctionJul 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND THE ABSORBABLE STRAP WAS USED. IT WAS REPORTED THAT THE DEVICE MALFUNCTIONED DURING THE PROCEDURE. IT WAS ALSO REPORTED THAT THE SURGEON, DURING THE STAPLING, REALIZED THAT TWO SETS OF STAPLES WERE DELIVERED IN A SINGLE PRESSURE. THESE STAPLES WERE ALSO DELIVERED IN A BAD POSITION: THEY WERE PUT IN CROSS. IT WAS REPORTED THAT THE SURGEON TRIED TO REMOVE THEM AFTERWARDS, BUT SOME COULD NOT BE REMOVED AND THE SURGEON IS AFRAID THAT THIS PERFORATES THE HAILSTONE AFTERWARDS, POST-OPERATIVELY IMMEDIATE OR DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15023427 ↗