Alexis O Wound Protector-Retractor C8402Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607915117269), received between Mar 4, 2017 and Jul 3, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: THP/ ANTERIOR APPROACH. DESCRIPTION OF EVENT: (NAME REDACTED) STARTED HIS PROCEDURES WITH THE ALEXIS O RIDGID. HE NOTICED THE SHEET TEARED. THEN HE STARTED TO USE THE ALEXIS ORTHO. IN 90% OF CASES, HE USES THE ANTERIOR APPOACH AND ALEXIS ORTHO. HE'S USING A RELATIVELY LARGE INCISION. PLACEMENT OF THE SHEET AFTER THE FEMURHEAD IS REMOVED. HE TRIED TO PLACE IT BEFORE BUT HE STATES THAT HE HAS LESS SPACE AND MOVED AWAY FROM THAT. FOR THE OTHER CASES (REVISIONS AND DISPLASIA) HE USES THE LATERAL APPROACH AND NO ALEXIS ORTHO. HE USES A RALATIVELY LARGE INCISION (NO BIKINY INCISION DUE TO MORE WOUND COMPLICATIONS IN RELATION TO STRAIGHT INCISIONS. MORE GRANULATION TUSSUE IN THE GROIN IS SEEN IF BIKINY INCISIONS ARE USED.) ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 28JUN24: 1.IT WAS IN THE MIDDLE OF THE PLASTIC SHEET WERE THE BROACH SOMETIMES CATCHES UP ON THE SHEET (ALEXIS O RIDGID AND ALEXIS ORTHOPEDIC). 2.MALFUNCTION OCCURRED WHEN USING THE BROACH INTO THE FEMUR. 3. DUE TO THE ANGLE OF THE OPERATIONS THE SURFACE OF THE BROACH COMES INTO CONTACT WITH THE SHEET EASILY. ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 02JULY24: THE PROD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669290 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC ILEOCECECTOMY. EVENT DESCRIPTION: COMPLAINT CREATED BASED ON MEDWATCH RECEIVED VIA EMAIL. REPORT NUMBER (B)(4). "DURING THE PROCEDURE AN ALEXIS WOUND RETRACTOR WAS OPENED TO BE USED, UPON THE SURGEON UNRAVELING THE ALEXIS WOUND RETRACTOR A SMALL PIECE OF PLASTIC LIKE MATERIAL FELL OUT. THE FOREIGN MATERIAL WAS THEN PLACED IN A SPECIMEN CUP AND REMOVED OFF THE FIELD. MANAGEMENT WAS NOTIFIED AND THE OBJECT WAS HANDED OFF TO THEM." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 24MAR2023 FROM [NAME], QUALITY COORDINATOR, [NAME] HOSPITAL . WHEN ASKED IF ANY PATIENT INJURY OCCURRED THE CONTACT RESPONDED "NOT THAT I AM AWARE OF." PATIENT STATUS IS "UNKNOWN". NO INSTRUMENTS WERE USED "AT THE TIME THAT THIS OCCURRED. IT WAS OPENED TO USE AND THE PIECE FELL INTO THE PATIENT." ALL PIECES WERE RETRIEVED FROM THE PATIENT. WHEN ASKED HOW THE CASE WAS COMPLETED THE RESPONSE WAS "YES". WHEN ASKED IF THE PIECE THAT FELL INTO THE PATIENT WAS THIN AND CLEAR LIKE THE SHEATH OR IF IT WAS GREEN OR WHITE LIKE PART OF THE RINGS THE RESPONSE WAS "IT WAS MADE OUT OF THE MATERIAL OF THE ITEM". "WE TYPICALLY DO NOT RETURN DEVICES. WE KEPT PACKAGE AND THE PIECE THAT FELL OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745275 ↗
• MalfunctionFeb 7, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: CLEAR PLASTIC RIPPED WHILST IN USE. PATIENT STATUS: NO PATIENT INJURY AND PATIENT STATUS IS UNKNOWN. TYPE OF INTERVENTION: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9682099 ↗
• MalfunctionDec 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: HIP PROCEDURE - ANTERIOR HIP ARTHROPLASTY. DETAILED DESCRIPTION OF EVENT: "WOULD LIKE TO NOTIFY YOU THAT AN ALEXIS WOUND RETRACTOR CAT# C8204 LOT#: 1365929 EXPIRATION: 08/18/2022 TORE DURING A PROCEDURE." THE ACCOUNT MANAGER SPOKE WITH AND RECEIVED AN EMAIL FROM THE CUSTOMER ON 22NOV2019. THE CUSTOMER REPORTED THAT NO PATIENT INJURY OCCURRED. THE DATE OF THE EVENT WAS 21NOV2019. LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. IT WAS UNKNOWN WHAT INSTRUMENTS WERE IN USE AT THE TIME OF THE EVENT. IT WAS UNKNOWN WHAT TYPE OF PROCEDURE WAS BEING PERFORMED. THE DEVICE IS AVAILABLE FOR RETURN. THE ACCOUNT MANAGER FORWARDED THE EMAIL TO APPLIED MEDICAL AT THE SAME TIME AS HE CALLED IN THE COMPLAINT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26DEC2019 FROM [NAME] ACCOUNT MGR: "CUSTOMER STATED THAT SURGEON WAS USING ALEXIS-O DURING A HIP PROCEDURE. SHARP INSTRUMENTS AND/OR RETRACTORS CAUSED THE ALEXIS-O TO TEAR DURING THE PROCEDURE. FACILITY WILL START CARRYING ALEXIS ORTHO TO ENSURE PATIENT SAFETY." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30DEC2019 FROM [NAME] ACCOUNT MGR: "CASE WAS AN ANTERIOR HIP ARTHROPLASTY. 'HIT WITH AN INSTRUMENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468863 ↗
• MalfunctionDec 11, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NA (RECEIVING INSPECTION). DETAILED DESCRIPTION OF EVENT: CER 1 OF 3: 2019-002370 - C8304 LOT# 1358751 - BUG IN POUCH - 1 POUCH CER 2 OF 3: 2019-002386 - C8402 LOT# 1358548 - IMPERFECT HEAT SEAL - 1 POUCH CER 3 OF 3: 2019-002463 - G6313 LOT# 1358693 - TORN SHEATH - 1 POUCH THE PRODUCT DID NOT PASS THE INCOMING INSPECTION OF PO#19-10APP BECAUSE OF BUG. DETAILS ARE SHOWN ON THE ATTACHED FILE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30SEP2019 FROM APPLIED MEDICAL DIRECTOR PACKAGING: "PACKAGING WILL NEED A CER FOR ITEM 10 (IMPERFECT HEAT SEAL)." PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 9453822 ↗
• MalfunctionAug 14, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED: THORACOTOMY. EVENT DESCRIPTION: SHEATH TORE. IT WAS REPORTED THAT THE FACILITY IS NOT SURE HOW THE TEAR OCCURRED. NO METAL RETRACTORS WERE USED OVER THE DEVICE. THE SURGEON HAS USED THE ALEXIS FOR A THORACOTOMY PROCEDURE PREVIOUSLY WITHOUT INCIDENT. NO PATIENT INJURY. NO ADDITIONAL INFORMATION REGARDING THE LOCATION OF THE TEAR NOR THE TIMING OF THE TEAR DURING THE PROCEDURE. NO ADDITIONAL INFORMATION REGARDING HOW THE TEAR OCCURRED OR HOW THE PROCEDURE WAS COMPLETED. TYPE OF INTERVENTION: NA. PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6793279 ↗
• MalfunctionMar 4, 2017Break; Break

  LAPAROSCOPIC RIGHT HEMI COLECTOMY- "ON REMOVAL THE PLASTIC SHEATH CAME AWAY FROM THE WHITE RIGID RING AND ENDED UP BACK INSIDE THE PATIENT. NO FORCE WAS USED BY THE SURGEON AND THEY HAVE USED THIS PRODUCT FOR A NUMBER OF YEARS." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378857 ↗