Alexis O Wound Protector-Retractor C8401Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00607915117252), received between Mar 4, 2017 and Feb 12, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI EVENT DATE: UNKNOWN EVENT DESCRIPTION: I HAVE BEEN ALERTED BY MY CLINICAL COLLEAGUE (NAME REDACTED) THAT WHILST IN THE OPERATING THEATRE 2 OF YOUR PRODUCT C8401 HAVE BROKEN WHILST IN USE. (NAME REDACTED) WILL BE ABLE TO HAVE THE APPROPRIATE TEAM MEMBER EXPLAIN THE BEHAVIOR OF THIS ITEM PRIOR TO USE AND WHILST IN USE IN A HOPE YOUR TEAM CAN WORK OR THE CAUSATION OF THIS OCCURRENCE. THE LOT NUMBERS OF BOTH USED ALEXIS RING (SMALL) IS AS FOLLOWS (1550713). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2026: IMAGES IN THE ATTACHMENTS. I HAVE REQUESTED THE BELOW INFORMATION FROM THE CUSTOMER AND HAVE ATTACHED 2 PICTURES THEY SENT TO ME. AS SOON AS I CAN OBTAIN ANY ADDITIONAL INFORMATION I WILL INFORM YOU. INTERVENTION: NI PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328322 ↗
• MalfunctionFeb 12, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: I HAVE BEEN ALERTED BY MY CLINICAL COLLEAGUE (NAME REDACTED) THAT WHILST IN THE OPERATING THEATRE 2 OF YOUR PRODUCT C8401 HAVE BROKEN WHILST IN USE. (NAME REDACTED) WILL BE ABLE TO HAVE THE APPROPRIATE TEAM MEMBER EXPLAIN THE BEHAVIOR OF THIS ITEM PRIOR TO USE AND WHILST IN USE IN A HOPE YOUR TEAM CAN WORK OR THE CAUSATION OF THIS OCCURRENCE. THE LOT NUMBERS OF BOTH USED ALEXIS RING (SMALL) IS AS FOLLOWS (B)(6). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27JAN2026: IMAGES IN THE ATTACHMENTS. I HAVE REQUESTED THE BELOW INFORMATION FROM THE CUSTOMER AND HAVE ATTACHED 2 PICTURES THEY SENT TO ME. AS SOON AS I CAN OBTAIN ANY ADDITIONAL INFORMATION I WILL INFORM YOU. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328310 ↗
• MalfunctionApr 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC ILEOSTOMY CLOSURE EVENT DESCRIPTION: DURING OPERATION AND REMOVAL, BOTH THE ALEXIS AND [COMPETITOR] BAGS ([COMPETITOR] IS AN [COMPETITOR] PRODUCT) BROKE APART IN THE PATIENT AND ALL PIECES WERE REMOVED FROM THE PATIENT SUCCESSFULLY AND SAVED FOR RETURN. ADDITIONAL INFORMATION PROVIDED BY ACCOUNT MGR ON 04MAR2025 VIA EMAIL: I CAN CONFIRM THAT IT WAS A [COMPETITOR] BAG THAT ALSO BROKE. INTERVENTION: PIECES WERE SUCCESSFULLY REMOVED FORM PATIENT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758855 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: VATS DESCRIPTION OF EVENT: COMPLAINT 1 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA. COMPLAINT 2 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA. TWO DEVICE MALFUNCTIONS OCCURRED DURING THE SAME PROCEDURE. [HOSPITAL] I¿M HERE AT THE [FACILITY] IN ANOTHER VATS CASE. 2 MORE ALEXIS TORE AT THE RING. SAME LOT NUMBER AS THE PREVIOUS ONE: LOT # 1506767. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 28AUG2024: THEY ARE GOING TO SAVE THE 2 FROM TODAY TO SEND BACK TO CORPORATE THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: NO PATIENT INJURY OCCURRED. THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. THE FIRST ALEXIS SHEATH TORE MID-PROCEDURE. THE SECOND ALEXIS TORE MID-PROCEDURE. SUCTION, BOVIE, AND STAPLER WERE USED WITHIN THE ALEXIS. THE SHEATH DID NOT PARTICULATE. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: THEY WILL RETURN THE 2 ALEXIS THAT WERE USED IN THE CASE YESTERDAY. INTERVENTION: THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263016 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: VATS DESCRIPTION OF EVENT: COMPLAINT 1 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA - MFR# 2027111-2024-00833. COMPLAINT 2 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA - MFR# 2027111-2024-00834. TWO DEVICE MALFUNCTIONS OCCURRED DURING THE SAME PROCEDURE. [HOSPITAL]: I¿M HERE AT THE [FACILITY] IN ANOTHER VATS CASE. 2 MORE ALEXIS TORE AT THE RING. SAME LOT NUMBER AS THE PREVIOUS ONE: LOT # 1506767. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 28AUG2024: THEY ARE GOING TO SAVE THE 2 FROM TODAY TO SEND BACK TO CORPORATE THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: NO PATIENT INJURY OCCURRED. THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. THE FIRST ALEXIS SHEATH TORE MID-PROCEDURE. THE SECOND ALEXIS TORE MID-PROCEDURE. SUCTION, BOVIE, AND STAPLER WERE USED WITHIN THE ALEXIS. THE SHEATH DID NOT PARTICULATE. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: THEY WILL RETURN THE 2 ALEXIS THAT WERE USED IN THE CASE YESTERDAY. INTERVENTION: THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262804 ↗
• MalfunctionAug 27, 2024Break; Break

  PROCEDURE PERFORMED: COLECTOMY. DESCRIPTION OF EVENT: [HOSPITAL] PRODUCT: C8401. DURING THE CASE, THE DOCTOR TRIED ROLLING THE ALEXIS ONLY ONCE ROLLING THEN THE RETRACTION RING(WHITE) WAS BROKEN. NO PRODUCT RETURNING. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080817 ↗
• MalfunctionMay 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE PERFORMED: LAMINECTOMY. DESCRIPTION OF EVENT: [FACILITY] ENGLISH VERSION OF EVENT DESCRIPTION: WHEN THE ATTENDING PHYSICIAN REMOVED ALEXIS AT THE END OF SURGERY, HE CHECKED THE SURFACE OF ALEXIS AND CONFIRMED THAT THERE WERE HOLES. THE SHAPE OF THE HOLES APPEARS TO BE CRUSHED VISUALLY. AT THAT TIME, IT WAS CONFIRMED WHETHER OR NOT THE DEBRIS HAD FALLEN INTO THE BODY CAVITY, THE DEBRIS WAS FOUND, AND THE CONFIRMED DEBRIS WAS TAKEN OUT. THE DOCTOR ALSO MATCHED THE PERFORATED ALEXIS WITH THE DEBRIS, BUT THE DOCTOR WASN'T SURE IF ALL THE DEBRIS COULD BE REMOVED FROM THE BODY CAVITY. THE FACILITY ASKS THE MANUFACTURER FOR THEIR VIEWS ON THE RISKS OF RESIDUAL DEBRIS IN THE BODY CAVITY. THE FACILITY STATED THAT THE INSTRUMENTS USED VIOLENTLY INTERFERED WITH ALEXIS DURING A SERIES OF SURGICAL PROCEDURES, WHICH IS BELIEVED TO BE THE CAUSE OF THE DAMAGE. THE POSTOPERATIVE COURSE OF THE PATIENT IS SO FAR GOOD. THE USED INSTRUMENTS ARE REAMER, DRILL, HAMMER, BONE SAW, BONE HEAD REMOVER, RASP AND SO ON. TRANSLATED JAPANESE VERSION OF EVENT DESCRIPTION: USED IN SURGERY FOR SPINAL CANAL STENOSIS. I USED IT ACCORDING TO THE ATTACHED TEXT, BUT WHEN I REMOVED THE RETRACTOR AFTER TH

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14338615 ↗
• MalfunctionAug 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: VATS. DETAILED DESCRIPTION OF EVENT: COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 1 OF 2 THAT OCCURRED IN THE SAME SURGERY. COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 2 OF 2 THAT OCCURRED IN THE SAME SURGERY. DETAILED DESCRIPTION OF EVENT: AFTER USING THE ALEXIS FOR "A WHILE" IT WAS NOTED THAT A TEAR HAD DEVELOPED IN THE SHEATH. THE DEVICE WAS REMOVED AND REPLACED. AFTER USING THE SECOND UNIT FOR "A WHILE" IT WAS NOTED AGAIN THAT THERE WAS A TEAR SOMEWHERE ON THE SHEATH. THE SECOND UNIT WAS REPLACED WITH A THIRD DEVICE AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. IT WAS UNKNOWN WHERE THE LOCATION OF THE TEARS WERE ON THE TWO SHEATHS. A NUMBER OF VARIOUS LAPAROSCOPIC INSTRUMENTS WERE USED DOWN THE DEVICE. THE EVENT DEVICES WERE DISCARDED AFTER THE CASE BY THE HOSPITAL AND THEY DID NOT REPORT THE INCIDENT UNTIL THE APPLIED ACCT. MGR. WAS AT THE FACILITY. NO PATIENT INJURY OCCURRED. LIMITED INFORMATION WAS AVAILABLE. PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE COMPLAINT EVENT. TYPE OF INTERVENTION: THE DEVICE WAS REPLACED WITH A THIRD DEVICE AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8876933 ↗
• MalfunctionJul 31, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE: VATS. DETAILED DESCRIPTION OF EVENT: COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 1 OF 2 THAT OCCURRED IN THE SAME SURGERY. COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 2 OF 2 THAT OCCURRED IN THE SAME SURGERY. AFTER USING THE ALEXIS FOR "A WHILE" IT WAS NOTED THAT A TEAR HAD DEVELOPED IN THE SHEATH. THE DEVICE WAS REMOVED AND REPLACED. AFTER USING THE SECOND UNIT FOR "A WHILE" IT WAS NOTED AGAIN THAT THERE WAS A TEAR SOMEWHERE ON THE SHEATH. THE SECOND UNIT WAS REPLACED WITH A THIRD DEVICE AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. IT WAS UNKNOWN WHERE THE LOCATION OF THE TEARS WERE ON THE TWO SHEATHS. A NUMBER OF VARIOUS LAPAROSCOPIC INSTRUMENTS WERE USED DOWN THE DEVICE. THE EVENT DEVICES WERE DISCARDED AFTER THE CASE BY THE HOSPITAL AND THEY DID NOT REPORT THE INCIDENT UNTIL THE APPLIED ACCT. MGR. WAS AT THE FACILITY. NO PATIENT INJURY OCCURRED. LIMITED INFORMATION WAS AVAILABLE. TYPE OF INTERVENTION: THE DEVICE WAS REPLACED WITH A THIRD DEVICE AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8846917 ↗
• MalfunctionMar 4, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED UNKNOWN - "DOCTOR JUST FLIPPED THIS DEVICE AND THEN THE FILM WAS BROKEN. PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378858 ↗