Alexis Laparoscopic System C8502Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00607915119935), received between Jan 4, 2017 and Apr 29, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: ANTERIOR RESECTION. EVENT DESCRIPTION: "IT WAS TORN." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 07APR2026 FROM [NAME], AMK TERRITORY MANAGER. "IT'S UNKNOWN DURING WHAT STEP IN THE PROCEDURE THE MALFUNCTION OCCURRED. IT'S UNKNOWN WHERE THE SHEATH SEPARATED/TORE FROM. IT'S IMPOSSIBLE TO PROVIDE THE PICTURES. IT'S UNKNOWN WHETHER ANY INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING PLACEMENT. IT'S UNKNOWN WHETHER ANY INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING THE PROCEDURE. IT'S UNKNOWN WHETHER IT PARTICULATED." INTERVENTION: NI. PATIENT STATUS: THERE WAS NO PROBLEM WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035360 ↗
• MalfunctionNov 1, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: UNKNOWN. DETAILED DESCRIPTION OF EVENT: AI TRANSLATED: 1. REF C8502: ALEXIS LAPAROSCOPIC SYSTEM M 5-9CM, A. UNSTERILE: HAIR FOUND BACK IN THE SEALED PACKAGE. PLEASE RETURN WHAT TO DO WITH THESE PIECES. OUR OPERATIONS QUARTER HAS NOTICED THAT A HAIR GOT CAUGHT IN A STERILE PACKED PRODUCT. EVENT DESCRIPTION IN PCF: WHEN TAKING THE ALEXIS, THEY SAW A HAIR IN THE PACKAGE (SEE PICTURES). PATIENT STATUS: PATIENT IS OK. TYPE OF INTERVENTION: THEY TOOK A NEW ALEXIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587419 ↗
• MalfunctionMar 29, 2024Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  PROCEDURE PERFORMED: RIGHT HEMICOLECTOMY. DESCRIPTION OF EVENT: [NAME] MEDICAL CENTER. "THE PACKAGING WAS FOUND TO BE OPENED BEFORE USE." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE ON 27MAR2024 FROM [NAME] AMK TERRITORY MANAGER "THERE WAS MISCOMMUNICATION BETWEEN THE HOSPITAL AND THE DEALER. THE EVENT IS NOT ABOUT THE OPEN PACKAGE. THE EVENT IS THAT THE SHEATH WAS FOUND TORN." TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE. PATIENT STATUS: NA (NOT USED ON PATIENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006986 ↗
• MalfunctionFeb 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. DESCRIPTION OF EVENT: ALEXIS IN USE & SPLIT. TYPE OF INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634104 ↗
• MalfunctionAug 10, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [FACILITY] INCOMING INSPECTION (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 THE ITEMS REQUIRE CER IN THIS REPORT. C8502 LOT #1448279 - PARTICULATE: SUSPECTED HAIR (1 EA.). PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204397 ↗
• MalfunctionNov 21, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED -LAP HEMI COLECTOMY. "THIS ALEXIS WAS NOTICED THAT IT WAS TORN, WHEN THE SCRUB NURSE UNPACK AND CHECK THE PRODUCT BEFORE USE, DURING THE SURGERY." PATIENT STATUS- NO PATIENT INJURY OR ILLNESS OCCURRED THAT WAS ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7049795 ↗
• MalfunctionJul 12, 2017Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: LAP DONOR NEPHRECTOMY EVENT DESCRIPTION: PART OF CAP BROKE OFF AND FELL IN PATIENT. THEY USE THE CAP TO INTRODUCE CD004 WITHOUT TROCAR. ADDITION INFORMATION RECEIVED ON TUESDAY, JULY 4, 2017 THAT THE HOSPITAL DOES NOT KNOW FOR SURE AT WHAT POINT THE CAP BROKE OFF, THEY NOTICED IT BECAUSE THERE WAS A LEAKAGE AFTER TISSUE REMOVAL WITH INZII. THEY DID NOT USE ANY OTHER INSTRUMENTS. WITH RESPECT TO EXPERIENCE THE SURGEON USED THE PRODUCT AROUND THE 3RD OR 4TH TIME. ONLY THE CAP WILL BE REMOVED, THEY THREW AWAY THE PIECE THAT BROKE OFF, SO THEY ONLY SAVED THE CAP. COMMENT FROM THE HOSPITAL: ''WE REMOVED THE KIDNEY AS USUAL THROUGH THE PORT AND PLACED THE CAP BACK ON THE ALEXIS. WE NOTICED THAT THERE WAS A LEAKAGE, VERY UNPLEASANT. WHEN WE CHECKED THE CAP FOR THE LEAKAGE WE NOTICED THAT A PART OF THE CAP WAS BROKEN OFF. A PIECE OF THE SEAL.''. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6709305 ↗
• MalfunctionJan 27, 2017Material Perforation; Material Perforation

  LAPAROSCOPIC COLECTOMY - "DURING USE THE DEVICE WAS TOTALLY TORN WITHOUT TRACTION." ORIGINAL: LORS DE L'UTILISATION, LE DISPOSITIF S'EST TOTALEMENT DÉCHIRÉ SANS TRACTION. ADDITIONAL INFORMATION RECEIVED FROM THE APPLIED MEDICAL TEAM MEMBER ON JANUARY 9, 2017: THE CUSTOMER USED THE DEVICE ON LAPAROSCOPIC COLECTOMY BUT DOESN'T REMEMBER THE DETAILS. THE PART OF THE DEVICE THAT WAS TORN WAS CONFIRMED TO BE THE SHEATH. USER DOES NOT REMEMBER IF THE DEVICE WAS TORN BEFORE, DURING OR AFTER INSERTION. PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6283053 ↗
• MalfunctionJan 4, 2017Material Perforation; Material Perforation

  LAPAROSCOPIC RIGHT HEMI COLECTOMY - "I WAS NOT PRESENT AT THE HOSPITAL OR CASE. THE SURGEON WAS REMOVING DEVICE FROM PATIENT AND NOTICED A TEAR IN THE ALEXIS SHEATH. SURGEON IS A REGULAR USER OF ALEXIS AND ADVISED SCRUB NURSE THAT THIS WAS NOT CAUSED BY THE SURGEON. MAIN CONCERN WAS THAT THERE MAY BE MATERIAL LEFT IN PATIENT - AFTER EXAMINATION, SURGEON HAPPY THIS WAS NOT THE CASE." PATIENT STATUS - "N/A".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6223599 ↗