Alexis O Wound Protector-Retractor C8403Recalls & reported problems
Applied Medical Resources Corporation · Wound Retractor and Protector · Class 2
All models of Alexis O Wound Protector-Retractor (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915117276), received between Mar 6, 2017 and Jul 31, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Material Perforation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
PROCEDURE PERFORMED: OPEN MYOMECTOMY. EVENT DESCRIPTION: THE SHEATH BROKE OFF OF THE RING. ADDITIONAL INFORMATION PROVIDED BY ACCOUNT MANAGER VIA EMAIL ON (B)(6) 2025: FROM PCF: ALEXIS BEING USED DURING/FOR OPEN MYOMECTOMY. ALEXIS RING DISCONNECTED FROM SHEATH INTERVENTION: USED NEW ALEXISE. PATIENT STATUS: NO INJURY DUE TO COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22682672 ↗MalfunctionDec 16, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO#(B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. PLEASE FIND ATTACHED SPREADSHEET. THERE ARE ITEMS REQUIRE CER IN THIS REPORT. C8403 LOT #1462152 - PARTICULATE: HAIR (1 EA.) PRODUCTS ARE AVAILABLE FOR RETURN. TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15999956 ↗MalfunctionMar 6, 2017Material Perforation; Material Perforation
"OVARIAN CYSTECTOMY - DURING INITIAL PLACEMENT OF THE ALEXIS THE RETRACTION RING ITSELF BECAME DETACHED AT THE CONNECTION AREA WHILE BEING ROLLED DOWN. [SURGEON] WAS THE GYNECOLOGIST USING THE PRODUCT DURING THE INCIDENT." TYPE OF INTERVENTION - "A SECOND C8403 WAS USED TO COMPLETE THE PROCEDURE." PATIENT STATUS - "NO ISSUES."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6380728 ↗
Other Ring (Wound Protector), Drape Retention, Internal devices
- Alexis Laparoscopic System C8501Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal18 reports
- Alexis Wound Protector-Retractor C8301Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal14 reports
- Alexis ® Orthopaedic Protector HR004Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal14 reports
- Alexis O Wound Protector-Retractor C8401Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal10 reports
- Alexis Laparoscopic System C8502Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal9 reports
- Alexis Wound Protector-Retractor C8312Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal7 reports
- Alexis O Wound Protector-Retractor C8402Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal7 reports
- Alexis Wound Protector-Retractor C8323Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page