Alexis O Wound Protector-Retractor C8405Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915127190), received between Nov 17, 2017 and Sep 5, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: ALEXIS RETRACTOR TORE IN USE. CLEAR FILM DETACHED FROM GREEN RING. REMOVED FROM ABDOMEN. RETAINED FOR INSPECTION. INTERVENTION: REMOVED FROM ABDOMEN. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986530 ↗
• MalfunctionOct 3, 2022Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  PROCEDURE PERFORMED: (B)(6). EVENT DESCRIPTION: BREAKAGE OF THE PLASTIC PART OF THE ALEXIS RETRACTOR, CLINICAL CONSEQUENCES OBSERVED: RISK OF RESIDUAL FRAGMENTS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 6SEP22: SHEATH BREAKING. RISK OF SMALL PARTS (FRAGMENTS) OF THE SHEATH ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 9SEP22: THE INCIDENT TOOK PLACE AT THE EMERGENCIES OR. NO MORE DETAILS AT THE MOMENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 20SEP22: THE INCIDENT TOOK PLACE AT THE EMERGENCIES OR BY NIGHT AND I DID NOT FIND ANYBODY WHO COULD EXPLAIN TO ME WHAT OCCURRED. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED. TYPE OF INTERVENTION: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15530178 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NAME OF PROCEDURE BEING PERFORMED: HIPEC EX LAP. DETAILED DESCRIPTION OF EVENT: ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM APPLIED MEDICAL HEALTH SYSTEMS SPECIALIST: THE DATE AN APPLIED TEAM MEMBER WAS MADE AWARE OF THE EVENT WAS 10/17/19. THE CUSTOMER ACCOUNT # (B)(4). THE FACILITY NAME IS [NAME]HOSPITAL. THE DATE OF THE EVENT WAS (B)(6) 2019. THE MODEL # WAS C8405. THE LOT# WAS 1358099. THE PROCEDURE BEING PERFORMED WAS A HIPEC EX LAP. THE DESCRIPTION OF THE EVENT WAS: PT HAS NEUROPATHY POST OP. THE CASE WAS COMPLETED WITH ALEXIS O AND BOOK WALTER. THE PATIENT STATUS IS NEUROPATHY. THE CONCOMITANT DEVICES USED WITH THE ALEXIS WERE BOOK WALTER AND HAND HELD METAL RETRACTORS. THE SURGEON/OR TEAM USED ALEXIS USED MULTIPLE TIMES SINCE INCIDENT WITH NO ISSUES. DID NOT ANSWER THE QUESTION ASKED WHICH WAS HAD THEY USED IT BEFORE. THERE WERE NO ISSUES WITH THE ALEXIS THAT LEAD THEM TO USE THE RETRACTOR WITH THE ALEXIS. THEY USE THE BOOK WALTER TO ELEVATE THE ABDOMEN FOR EXPOSURE. THE SURGEON DID SWEEP BOWELS AROUND INNER RING BEFORE ROLLING DOWN ALEXIS. THE DEVICE IS NOT AVAILABLE TO BE RETURNED, IT WAS DISCARDED BY FACILITY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON

  Patient problems: Nerve Damage

  MAUDE report 9216618 ↗
• MalfunctionNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL, ON FROM SENIOR REGULATORY AFFAIRS SPECIALIST, ON JANUARY 3, 2018. "THIS HOSPITAL MOST PROBABLY RECEIVED THOSE LOTS DIRECTLY FROM THE SALES REP BECAUSE THEY ARE DOING A SPECIFIC STUDY WITH THE (B)(6)IT MEANS THAT MODEL NUMBER REGARDING THESE CERS IS DEFINITELY C8404 (AS PER MDV REPORT) AND NOT AS INFORMED." ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL TM ON JANUARY 8, 2018: "BASED ON THE LOT TRACE, HOWEVER, LOT NUMBER INDEED DOESN'T MATCH WITH THESE INCIDENTS. THIS LOT WAS DELIVERED TO THE HOSPITAL ONLY IN OCTOBER (AFTER THE INCIDENTS), AND THERE`S NO TRACE THAT WAS DELIVERED EVEN TO THE REP. CUSTOMER MOST LIKELY GAVE US A WRONG LOT NUMBER, PROBABLY WHAT THEY STILL HAD ON THEIR SHELVES. CONSIDERED THE ABOVE EXPLANATION, LOT TRACE ATTACHED AND COMMUNICATION BACK AND FORTH BETWEEN US, THE REP AND CLINICAL TEAM IN AME, WE CONCLUDED THAT FOR THESE CERS THE LOT NUMBER IS UNKNOWN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7043527 ↗