REFLEX 3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20653405050602), received between Oct 26, 2022 and Oct 2, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionOct 2, 2023Failure to Fire; Failure to Fire

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 3013, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE, WAS INITIALLY BEING RETURNED DUE TO A SHIPPING ERROR. HOWEVER, UPON THE WAREHOUSE¿S RECEIPT OF THE RETURNING DEVICE AN INVOICE IN THE BOX FOUND THAT THE REASON FOR RETURN WAS NOT AS PREVIOUSLY REPORTED. THE INVOICE STATED, ¿THAT THE REFLEX STAPLER DID NOT RELEASE TISSUE WHEN STAPLER IS RELEASED RESULTING IN IMPROPER PLACEMENT OF STAPLES ALONG INCISION AND JAMMING OF STAPLER.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850273 ↗
• MalfunctionSep 27, 2023Failure to Form Staple; Failure to Form Staple

  THE CUSTOMER REPORTED THAT THE DEVICE, 3013, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿WE ARE HAVING ISSUES WITH THE SKIN STAPLES RECENTLY AND WAS WANDERING IF WE MAY HAVE A BAD BATCH. THERE HAVE BEEN SEVERAL CONSULTANTS COMPLAINING OF THE SAME ISSUE SAYING THEY ARE NOT CLOSING THE SKIN ON BOTH SIDES JUST ON ONE SIDE. WE HAVE HAD ISSUE POST OPERATIVELY TOO WHERE THE STAPLES ARE COMING LOOSE AND FALLING OUT.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE PATIENTS WOUND NEEDED TO BE REDRESSED DUE TO A SPOILED DRESSING FROM WOUND COMING OPEN FROM THE STAPLES FALLING OUT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825529 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE DEVICE, 3013, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE WAS BEING USED ON APPROXIMATELY ON (B)(6) 2022 AND THE ¿STAPLES DO NOT COME OUT PROPERLY, SO THE ADHESION OF THE SKIN DOES NOT HOLD." THE PROCEDURE WAS NOT COMPLETED AND ¿WOULD HEALING DISRUPTED¿. AFTER FURTHER ASSESSMENT IT WAS DISCOVERED THAT THE CUSTOMER CONFIRMED IT WAS JUST THE WRONG SIZE OF STAPLE AS THEY ARE USED TO. IT WAS ACTUALLY DOWN TO THE WAY THEY USED THE ARTICLE. NOTHING OF COMPLAINT IN TERMS OF THE ARTICLE. NO OTHER INFORMATION WAS RECEIVED, SO IT IS UNKNOWN IF THE PATIENT RECEIVED TREATMENT OR THE PATIENT'S CURRENT CONDITION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO WOUND HEALING DISRUPTED.

  Patient problems: Insufficient Information

  MAUDE report 15672466 ↗