Alexis ® O C-Section Protector - Retractor G6313Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00607915118129), received between Feb 27, 2017 and Sep 24, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Insufficient Device Problem Information

  Patient problems: Perforation

  MAUDE report 50891466 ↗
• MalfunctionMar 6, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: OPEN MYOMECTOMY. EVENT DESCRIPTION: ACCOUNT MANAGER WAS PRESENT DURING THE PROCEDURE. DURING THE PROCEDURE, THE SURGEON AND NURSE BOTH NOTICED THAT THE POLYURETHANE AT THE BOTTOM OF THE UNIT WAS RIPPED. THEY REMOVED THE RIPPED DEVICE AND COMPLETED THE SURGERY WITH A SECOND UNIT. PHOTO WILL BE PROVIDED. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 06FEB2026 VIA EMAIL: OPEN MYOMECTOMY. NO OTHER DISPOSABLES, BLUNT INSTRUMENTATION ONLY. SEPARATED FROM THE FILM ITSELF. NO OTHER INSTRUMENTS USED DURING INSERTION. DURING THE PROCEDURE, RICHARDSON RETRACTOR AND VARIOUS CLAMPS, CAUTERY BUT IT REMAINED IN ITS PROTECTIVE HOLDER UNLESS ACTIVE IN THE SURGEONS HAND, NONE USED ON THE ALEXIS RETRACTOR. AS FOR PARTICULATION - NOT THAT WAS VISIBLE OR IDENTIFIED. IMMEDIATELY UPON THE VISUALIZATION OF THE SEPARATION OF THE FILM OF THE ALEXIS, IT WAS REMOVED AND REPLACED WITH A NEW ALEXIS RETRACTOR. INTERVENTION: USED ANOTHER UNIT TO COMPLETE THE SURGERY. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531998 ↗
• MalfunctionFeb 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: C-SECTION. EVENT DESCRIPTION: [HOSPITAL], MODEL #: G6313, LOT #: 1516917. THE DEVICE RIPPED. THEY DID NOT REPLACE WITH A NEW ALEXIS, AND METAL RETRACTORS WERE USED TO COMPLETE THE PROCEDURE. NO HARM TO PATIENT. THE DEVICE WILL NOT BE RETURNING AND WAS DISCARDED. INTERVENTION: METAL RETRACTORS WERE USED. PATIENT STATUS: NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368585 ↗
• MalfunctionJan 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: COLECTOMY. EVENT DESCRIPTION: AI TRANSLATED: INCIDENT WHICH OCCURRED ON (B)(6) 2024 CONCERNING AN ALEXIS RETRACTOR WITH COMMERCIAL REFERENCE (B)(4) AND BATCH NUMBER. 1525898 FROM THE APPLIED MEDICAL FRANCE LABORATORY. USE OF AN ALEXIS RETRACTOR WHICH SPLIT WHEN DURING USE FOR A COLECTOMY, WHICH WAS NOTICED BY THE TEAM DURING WASHING. NO CLINICAL CONSEQUENCES FOR THE PATIENT. THIS IS NOT A RECURRING PROBLEM. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 26FEB25: IT WAS AT THE END OF THE PROCEDURE. THEY DID NOT USE ANOTHER DEVICE AT THIS MOMENT. IT DID NOT PARTICULATE. WE COULD NOT SEE WHERE IT WAS BROKEN. IT'S IN A BAG. INTERVENTION: THEY NOTICED IT AT THE END OF THE PROCEDURE SO THEY DID NOT REPLACE IT. PATIENT STATUS: NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234925 ↗
• MalfunctionFeb 28, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: C-SECTION. DETAILED DESCRIPTION OF EVENT: DURING THE PROCEDURE THE ALEXIS SHEATH TORE IN THE MIDDLE. IT IS UNKNOWN IF OTHER INSTRUMENTS WERE USED WITHIN THE ALEXIS. THERE WERE NO REMNANTS FROM THE TEAR. FINISHED CASE WITH THE DEVICE AND REMOVED. ALL MATERIAL WAS RETRIEVED. THERE WAS NO PATIENT INJURY. PHOTOS ARE NOT AVAILABLE. THE DEVICE WILL BE RETURNED. MEDWATCH RECEIVED VIA MAIL ON 20FEB2020. MEDWATCH REPORT NUMBER: MW5092808. DATE FDA RECEIVED: 05FEB2020. "VOLUNTARY 06-FEB-2020 12:23:28.00: ALEXIS O C-SECTION PROTECTOR/RETRACTOR CLEAR PLASTIC TORE DURING A C-SECTION PROCEDURE UNDER NORMAL USE. FDA SAFETY REPORT ID# (B)(4)." PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: COMPLETED THE CASE WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771891 ↗
• MalfunctionMar 13, 2018Material Fragmentation; Material Perforation; Material Fragmentation; Material Perforation

  PROCEDURE PERFORMED: UNK. (B)(4) RECEIVED VIA MAUDE DATABASE: (B)(4). EVENT DESCRIPTION: "WHEN REMOVING A PORTION OF THE STOMACH VIA THE PORT SITE, THE ALEXIS WOUND PROTECTOR BROKE. A PORTION OF THE WOUND PROTECTOR WAS IN THE ABDOMEN. THE SURGEON REMOVED THE COMPLETE BROKEN PORTION THAT WAS IN THE ABDOMEN. X-RAY WAS OBTAINED. X-RAY WAS NEGATIVE." TYPE OF INTERVENTION: "THE SURGEON REMOVED THE COMPLETE BROKEN PORTION THAT WAS IN THE ABDOMEN." PATIENT STATUS: UNK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7335029 ↗
• MalfunctionJan 3, 2018Material Perforation; Material Perforation

  PROCEDURE PERFORMED: EXCISION BIOPSY CERVICAL NODE INCIDENT DESCRIPTION: FIRST TIME MEETING [PHYSICIAN] WHO IS AN ENT SURGEON. AGREED TO TRY AN ALEXIS FOR HIS EXCISION BIOPSY OF CERVICAL NODE. IN SERVICED ON HOW TO USE BEFORE THE PROCEDURE AND SHOWED HIM AND HIS REGISTRAR A VIDEO OF THE ALEXIS BEING USED IN A THYROIDECTOMY. AFTER MAKING HIS INCISION AND SKIN FLAP HE TRIED TO PLACE THE XS AKEXIS BUT IT WAS TOO LARGE. I OPENED A STERILE XXS WHICH FIT IN THE SKIN FLAP. WHEN ROLLING THE ALEXIS DOWN [PHYSICIAN] AND [HIS REGISTRAR] HELD THE OUTER RING EITHER SIDE AND ROLLED DOWNWARDS. THE SHEATH BECAME TWISTED AS THEY ROLLED DOWN SO THEY WERE UNABLE TO GET THE CIRCUMFRIENTAL RETRACTION. THEY TRIED TO CORRECT THE TWIST BUT IT DIDN'T WORK SO THEY REMOVED THE ALEXIS BY BULLING THE STRING THROUGH THE MIDDLE. WHEN THE ALEXIS WAS PASSED TO THE SCRUB NURSE I NOTICED IT HAD TORN WHERE THE SHEATH WAS TWISTED OVER THE OUTER RING. MENTIONED TO THE SURGEON ABOUT THE RIP AND HE WAS AWARE OF THE RIP AND THINKS HE MAY HAVE CAUSED IT WHEN ROLLING THE SHEATH DOWN . PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO. TYPE OF INTERVENTION: NI.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162466 ↗
• MalfunctionNov 21, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PROCEDURE PERFORMED - LOWER SEGMENT CAESAREAN SECTION. INCISION SIZE MEASURED- 12.5 CM. ALEXIS INSERTED AND ROLLED DOWN. YELLOW PLACEMENT RING WAS FOLDED INWARDS, OBSTRUCTING THE OPERATING FIELD. WHILST BABY WAS DELIVERED, ALEXIS CAME OUT OF SITU. WHEN REINSERTING ALEXIS O C SECTION, IT WOULD NOT STAY IN PLACE. ANOTHER ALEXIS O C SECTION WAS USED. TYPE OF INTERVENTION - ANOTHER ALEXIS O C SECTION WAS USED. PATIENT STATUS -DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7049734 ↗
• MalfunctionMar 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  TOTAL ABDOMINAL HYSTERECTOMY - "ALEXIS FLEXIBLE RING WOULDN'T CONFORM TO PATIENT ANATOMY AND KEPT POPPING OUT." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378860 ↗
• MalfunctionMar 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  TOTAL ABDOMINAL HYSTERECTOMY - "(B)(6) FLEXIBLE RING WOULDN'T CONFORM TO PATIENT ANATOMY AND KEPT POPPING OUT." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378859 ↗
• MalfunctionFeb 28, 2017Material Perforation; Material Perforation

  "VATS. LOBECTOMY - AT THE END OF THE CASE WHEN REMOVING ALEXIS A SMALL TEAR WAS EVIDENT IN THE SHEATH. A NUMBER OF INSTRUMENTS WERE USED DURING THE CASE INCLUDING STAPLER, HOOK DIATHERMY, FORCEPS, GRASPERS AND SCISSORS." PATIENT STATUS - NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6366398 ↗
• MalfunctionFeb 27, 2017Material Perforation; Material Perforation

  VATS. LOBECTOMY - IN [SURGEON'S] SECOND CASE HE INSERTED 2 XXS ALEXIS AT START OF THE CASE. AT THE POINT OF REMOVING THE SPECIMEN (AROUND ONE HOUR INTO CASE) A SMALL TEAR NEAR THE GREEN RING OF THE ALEXIS WAS NOTICED AND WAS SUBSEQUENTLY REPLACED. AT THE END OF THE CASE ON REMOVING THE 2ND XXS ALEXIS ANOTHER SMALL TEAR AGAIN NEAR TO THE GREEN DEPLOYMENT RING WAS EVIDENT. DURING THE CASE A NUMBER OF INSTRUMENTS WERE PLACED THROUGH THE ALEXIS INCLUDING COVIDIEN STAPLER, DIATHERMY, FORCEPS AND SCISSORS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL TEAM MEMBER, FEBRUARY 8, 2017: ALL SURGEONS HAVE BEEN USING ALEXIS REGULARLY (XS & XXS) SINCE LAST QUARTER. ADDITIONAL INSTRUMENTS USED (NOT A DEFINITIVE LIST BUT MOST COMMONLY): DIATHERMY (HOOK), STAPLER (COVIDIEN/ETHICON), HEM-O-LOK AND VARIOUS INSTRUMENTS FROM THERE SET INCLUDING FORCEPS, SCISSORS, GRASPER & CLAMPS). [SURGEON] COMMENTED THAT IT MAY HAVE BEEN POSSIBLE THAT HE HAD CAUGHT THE SHEATH WITH HIS HOOK DIATHERMY. PATIENT STATUS - NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL TEAM MEMBER, FEBRUARY 8, 2017: "ALL FINE. NO PATIENT ILLNESS OR INJ

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6363311 ↗
• MalfunctionFeb 27, 2017Material Perforation; Material Perforation

  VATS. LOBECTOMY - AT THE END OF MR KIRKS CASE WHEN REMOVING THE XXS ALEXIS A SMALL TEAR WAS EVIDENT NEAR TO THE GREEN DEPLOYMENT RING. THE SAMPLE WAS NOT RETAINED HOWEVER IT WAS PULLED FROM THE SAME LOT (1274511) AS SUBSEQUENT CER ON (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL TEAM MEMBER, FEBRUARY 8, 2017: ALL SURGEONS HAVE BEEN USING ALEXIS REGULARLY (XS & XXS) SINCE LAST QUARTER. ADDITIONAL INSTRUMENTS USED (NOT A DEFINITIVE LIST BUT MOST COMMONLY): DIATHERMY (HOOK), STAPLER (COVIDIEN/ETHICON), HEM-O-LOK AND VARIOUS INSTRUMENTS FROM THERE SET INCLUDING FORCEPS, SCISSORS, GRASPER & CLAMPS). [SURGEON] COMMENTED THAT IT MAY HAVE BEEN POSSIBLE THAT HE HAD CAUGHT THE SHEATH WITH HIS HOOK DIATHERMY. PATIENT STATUS - NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL TEAM MEMBER, FEBRUARY 8, 2017: "ALL FINE. NO PATIENT ILLNESS OR INJURY OCCURRED IN ANY OF THE CASES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6363282 ↗
• MalfunctionFeb 27, 2017Material Perforation; Material Perforation

  VATS. LOBECTOMY - "TEAR IN THE SHEATH OCCURRED AS SURGEON WAS ROLLING DOWN THE ALEXIS." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL TEAM MEMBER, FEBRUARY 8, 2017: ALL SURGEONS HAVE BEEN USING ALEXIS REGULARLY (XS & XXS) SINCE LAST QUARTER. ADDITIONAL INSTRUMENTS USED (NOT A DEFINITIVE LIST BUT MOST COMMONLY): DIATHERMY (HOOK), STAPLER (COVIDIEN/ETHICON), HEM-O-LOK AND VARIOUS INSTRUMENTS FROM THERE SET INCLUDING FORCEPS, SCISSORS, GRASPER & CLAMPS). [SURGEON] COMMENTED THAT IT MAY HAVE BEEN POSSIBLE THAT HE HAD CAUGHT THE SHEATH WITH HIS HOOK DIATHERMY. PATIENT STATUS - NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL TEAM MEMBER, FEBRUARY 8, 2017: "ALL FINE. NO PATIENT ILLNESS OR INJURY OCCURRED IN ANY OF THE CASES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6363167 ↗