Alexis Laparoscopic System C8501Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00607915119928), received between Sep 13, 2016 and Mar 5, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NI (BEFORE USE). DETAILED DESCRIPTION OF EVENT: UPON OPENING PACKAGE DURING SURGERY PREP, THE NURSE FOUND A HAIR INSIDE THE PACKAGING. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20FEB2026 VIA EMAIL: THANK YOU FOR THE HELP, I HAVE TAKEN PHOTOS AND ATTACHED AS ASKED. IF THERE IS ANYTHING I CAN DO TO HELP, JUST LET ME KNOW. TYPE OF INTERVENTION: NI (BEFORE USE). PATIENT STATUS: NI (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515492 ↗
• MalfunctionNov 20, 2025Entrapment of Device; Entrapment of Device

  PROCEDURE PERFORMED: ROBOT-ASSISTED LOW ANTERIOR RESECTION EVENT DESCRIPTION: THIS IS A CER WHICH CAME FROM FEEDBACK. HOSPITAL [NAME]. COMPLAINT; WHAT HAPPENED. IN EARLY (B)(6) 2025, A PROBLEM HAPPENED DURING A ROBOT-ASSISTED LOW ANTERIOR RESECTION AT [FACILITY] (GASTROINTESTINAL SURGERY). THE SURGEON USED C8501 AS THE CAMERA PORT OF [ROBOT]. DURING THE OPERATION, A CLIP APPLIER INSERTED FROM ANOTHER PORT GOT CAUGHT ON THE TETHER CORD OF C8501. THE CORD WAS ENTANGLED WITH THE IMA (INFERIOR MESENTERIC ARTERY). THIS HAPPENED OUTSIDE THE CAMERA VIEW, SO IT WAS VERY DANGEROUS. THE SURGEON, DR. [NAME], SAID THERE MIGHT HAVE BEEN SLACK IN THE CORD INSIDE THE ABDOMEN. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20AUG2025: THE [ROBOT] PORT SETUP WAS: PORT 1: ASSIST PORT (RIGHT) PORT 2: CAMERA PORT 3: SURGEON¿S LEFT HAND PORT 4: SURGEON¿S RIGHT HAND THREE ARMS WERE USED. THE CLIP APPLIER WAS INSERTED FROM PORT 1 (ASSIST PORT), WHICH IS LOCATED TO THE RIGHT OF THE CAMERA PORT (PORT 2). THE SURGEON PLACED THE ALEXIS LAPAROSCOPIC SYSTEM (C8501). NOTE: THE CAP WAS NOT USED. THE TETHER WAS KEPT OUTSIDE THE PATIENT. WE COULD NOT CONFIRM WHETHER THE SURGEON SWEEPED THE INNER RING AFTER DEPLOYING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612482 ↗
• MalfunctionDec 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAP. RESECTION RECTOPEXY. DESCRIPTION OF EVENT: THE ALEXIS WAS PLACED INTO AN EXTENDED TROCAR INCISION, THE OUTER RETRACTION RING WAS ROLLED SEVERAL TIMES OUTWARDS FOR RETRACTION, THEN THE CAP WAS PLACED ONTO THE OUTER EXTRACTION RING AND TROCAR HAS BEEN INSERTED THROUGH THE CAP. WHEN TRYING TO REESTABLISH PNEUMOPERITONEUM A LEAKAGE WAS DETECTED. WHEN LOOKING FOR THE SOURCE THE ALEXIS SHEATH WAS IDENTIFIED AS THE PROBLEM. THE MATERIAL HAD A LARGE ALMOST 180° RIFT. NO CLINICAL IMPACT TO THE PATIENT, THERE WAS ONLY A LOSS OF TIME. THE SURGEON EXTRACTED THE ALEXIS LAP. SYSTEM, LIGATED THE FASCIA AND REINSERTED A TROCAR THROUGH A SMALL LEFTOVER GAP. NO OTHER INSTRUMENTS USED- THE SURGEON ALSO POINTED OUT THAT NO SHARP INSTRUMENTS COULD HAVE CAUSED THE DAMAGE. IMAGES AVAILABLE IN ATTACHMENTS. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 21NOV23: THE SURGEON USED A REUSABLE TROCAR WITHOUT OBTURATOR. THE INSUFFLATION-PRESSURE WAS SET TO 12 MMHG. IT WAS A FIRST INCISION. NO SUTURES OR STAPLES, NO PREVIOUS SURGERIES. TYPE OF INTERVENTION: THE SURGEON EXTRACTED THE ALEXIS LAP. SYSTEM, LIGATED THE FASCIA AND REINSERTED A TROCAR THROUGH A SMALL LEFTOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302898 ↗
• MalfunctionApr 11, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. AI TRANSLATION: EDGE OF THE LID OF THE GEL PORT ALEXIS HAS BEEN TORN OFF AND ENTERED THE PATIENT. INTERVENTION: N/I. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718650 ↗
• MalfunctionNov 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: "LAPAROSCOPIC ABDOMINAL PROCEDURE". EVENT DESCRIPTION: COMPLAINT CREATED BASED ON MEDWATCH RECEIVED BY EMAIL ON 05OCT2022. REPORT NUMBER MW5112223. "THE ALEXIS LAPAROSCOPIC SMALL WOUND RETRACTOR C8501 HAS A TRIANGULAR SHAPED PIECE THAT IS ATTACHED TO THE MAIN BODY OF THE RETRACTOR BY A [INVALID]. DURING A LAPAROSCOPIC ABDOMINAL PROCEDURE, IT WAS RECOGNIZED THAT THE TRIANGULAR PIECE WAS MISSING FROM THE [INVALID]. THE KNOT ATTACHING THE TRIANGULAR PIECE HAD APPARENTLY CAME UNDONE. AT THE TIME IT WAS RECOGNIZED, THE RETRACTOR WAS STILL IN THE BODY. THERE WAS CONCERN FOR A RETAINED FOREIGN BODY IN THE SURGICAL SITE. THE ITEM IS NOT RADIOPAQUE. THE PIECE WAS EVENTUALLY FOUND IN THE DRAPES BUT CONCERN FOR FUTURE USE AND RISK OF FOREIGN BODY RETENTION, ESPECIALLY WHEN NOT RADIOPAQUE, REMAINS. (NOTE THAT THE REPRESENTATIVE DID SAY IT WOULD BE SEEN ON MRI.) FDA SAFETY REPORT ID #(B)(4)." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 11OCT2022 FROM [NAME] THE TETHER DID NOT APPEAR TO BE BROKEN- IT APPEARED THAT THE SLIP KNOT HOLDING THE TETHER TAG CAME UNDONE. THE TETHER TAG WAS FOND IN THE DRAPES AT THE CONCLUSION OF THE PROCEDURE- IT IS NOT KNOWN AT EXACTLY WHAT PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712349 ↗
• MalfunctionSep 22, 2022Detachment of Device or Device Component; Incomplete or Inadequate Connection

  THE ALEXIS LAPAROSCOPIC SMALL WOUND RETRACTOR C8501 HAS A TRIANGULAR SHAPED PIECE THAT IS ATTACHED TO THE MAIN BODY OF THE RETRACTOR BY A [INVALID]. DURING A LAPAROSCOPIC ABDOMINAL PROCEDURE, IT WAS RECOGNIZED THAT THE TRIANGULAR PIECE WAS MISSING FROM THE [INVALID]. THE KNOT ATTACHING THE TRIANGULAR PIECE HAD APPARENTLY CAME UNDONE. AT THE TIME IT WAS RECOGNIZED, THE RETRACTOR WAS STILL IN THE BODY. THERE WAS CONCERN FOR A RETAINED FOREIGN BODY IN THE SURGICAL SITE. THE ITEM IS NOT RADIOPAQUE. THE PIECE WAS EVENTUALLY FOUND IN THE DRAPES BUT CONCERN FOR FUTURE USE AND RISK OF FOREIGN BODY RETENTION, ESPECIALLY WHEN NOT RADIOPAQUE, REMAINS. (NOTE THAT THE REPRESENTATIVE DID SAY IT WOULD BE SEEN ON MRI.) FDA SAFETY REPORT ID #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470454 ↗
• 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. C8501 LOT #1444855 - PARTICULATE: SUSPECTED HAIR (2 EA.). PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204342 ↗
• MalfunctionJun 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC SIGMOIDECTOMY. EVENT DESCRIPTION: TWO COMPLAINTS OCCURRED IN THE SAME CASE. COMPLAINT 1 OF 2: #(B)(4). COMPLAINT 2 OF 2: #(B)(4). FIELD TEAM WAS NOT PRESENT DURING DEVICE USE. THE FIRST C8501 WAS PLACED WITHIN PATIENT AND APPROXIMATELY 30 MINUTES AFTER DEPLOYMENT, THE SURGICAL TEAM FOUND THAT THE SHEATH WAS SEPARATED FROM THE GREEN INNER RING AND A PORTION OF THE RING WAS HANGING INSIDE THE PATIENT. A SECOND C8501 WAS USED AND THE SHEATH SEPARATED FROM THE GREEN INNER RING AGAIN 30 MINUTES AFTER DEPLOYMENT, SIMILAR TO THE FIRST C8501. THE CASE WAS COMPLETED WITH THE THIRD C8501. NO PATIENT INJURY OCCURRED. THE SURGICAL TEAM ALSO NOTE THAT THEY WOULD PULL OFF LOOPED CORD FROM DEVICE BEFORE USE, USING THE SAME PROCEDURE FOR 15 YEARS. IMAGES OF DEVICES ARE AVAILABLE PRODUCTS ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 VIA EMAIL FROM ACCOUNT MANAGER. THE GREEN PLACEMENT RING DETACHED FROM THE SHEATH 30 MINUTES AFTER DEPLOYMENT FOR BOTH DEVICES. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: CASE WAS COMPLETED WITH THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14748733 ↗
• MalfunctionJun 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC SIGMOIDECTOMY EVENT DESCRIPTION: TWO COMPLAINTS OCCURRED IN THE SAME CASE. COMPLAINT 1 OF 2: #(B)(6), COMPLAINT 2 OF 2: #(B)(6). FIELD TEAM WAS NOT PRESENT DURING DEVICE USE. THE FIRST C8501 WAS PLACED WITHIN PATIENT AND APPROXIMATELY 30 MINUTES AFTER DEPLOYMENT, THE SURGICAL TEAM FOUND THAT THE SHEATH WAS SEPARATED FROM THE GREEN INNER RING AND A PORTION OF THE RING WAS HANGING INSIDE THE PATIENT. A SECOND C8501 WAS USED AND THE SHEATH SEPARATED FROM THE GREEN INNER RING AGAIN 30 MINUTES AFTER DEPLOYMENT, SIMILAR TO THE FIRST C8501. THE CASE WAS COMPLETED WITH THE THIRD C8501. NO PATIENT INJURY OCCURRED. THE SURGICAL TEAM ALSO NOTE THAT THEY WOULD PULL OFF LOOPED CORD FROM DEVICE BEFORE USE, USING THE SAME PROCEDURE FOR 15 YEARS. IMAGES OF DEVICES ARE AVAILABLE PRODUCTS ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 02JUN2022 VIA EMAIL FROM ACCOUNT MANAGER. THE GREEN PLACEMENT RING DETACHED FROM THE SHEATH 30 MINUTES AFTER DEPLOYMENT FOR BOTH DEVICES. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: CASE WAS COMPLETED WITH THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14748720 ↗
• MalfunctionJun 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC COLECTOMY. SIMILAR C8501 MALFUNCTIONS OCCURRED IN 3 CASES. COMPLAINT 1 OF 3: #(B)(4). COMPLAINT 2 OF 3: #(B)(4). COMPLAINT 3 OF 3: #(B)(4) PRODUCT RETURNING. EVENT DESCRIPTION: EVENT DATE WAS SOMETIME IN THE PAST WEEK. C8501 WAS PLACED WITHIN PATIENT WITH 12MM TROCAR AND NO SHARP INSTRUMENTS INSERTED. APPROXIMATELY 1 HOUR INTO THE CASE, THE SURGICAL TEAM HEARD LEAKING AND FOUND THAT THE SHEATH WAS SEPARATED FROM THE GREEN INNER RING. A PORTION OF THE RING WAS HANGING FREELY FROM THE SHEATH INSIDE THE PATIENT. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT INJURY OCCURRED. PRODUCT IS NOT AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OCCURRED. TYPE OF INTERVENTION: A NEW DEVICE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14581973 ↗
• MalfunctionJun 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC COLECTOMY. SIMILAR C8501 MALFUNCTIONS OCCURRED IN 3 CASES. COMPLAINT 1 OF 3: #2022-001334 NPR. COMPLAINT 2 OF 3: #2022-001335 NPR. COMPLAINT 3 OF 3: #2022-001336 PRODUCT RETURNING. EVENT DESCRIPTION: EVENT DATE WAS SOMETIME IN THE PAST WEEK. C8501 WAS PLACED WITHIN PATIENT WITH 12MM TROCAR AND NO SHARP INSTRUMENTS INSERTED. APPROXIMATELY 1 HOUR INTO THE CASE, THE SURGICAL TEAM HEARD LEAKING AND FOUND THAT THE SHEATH WAS SEPARATED FROM THE GREEN INNER RING. A PORTION OF THE RING WAS HANGING FREELY FROM THE SHEATH INSIDE THE PATIENT. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT INJURY OCCURRED. PRODUCT IS NOT AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OCCURRED. TYPE OF INTERVENTION: A NEW DEVICE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14581967 ↗
• MalfunctionJun 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC COLECTOMY. SIMILAR C8501 MALFUNCTIONS OCCURRED IN 3 CASES. COMPLAINT 1 OF 3: #2022-001334 NPR. COMPLAINT 2 OF 3: #2022-001335 NPR. COMPLAINT 3 OF 3: #2022-001336 PRODUCT RETURNING. EVENT DESCRIPTION: EVENT DATE WAS SOMETIME IN THE PAST WEEK. C8501 WAS PLACED WITHIN PATIENT WITH 12MM TROCAR AND NO SHARP INSTRUMENTS INSERTED. APPROXIMATELY 1 HOUR INTO THE CASE, THE SURGICAL TEAM HEARD LEAKING AND FOUND THAT THE SHEATH WAS SEPARATED FROM THE GREEN INNER RING. A PORTION OF THE RING WAS HANGING FREELY FROM THE SHEATH INSIDE THE PATIENT. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT INJURY OCCURRED. PRODUCT IS NOT AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OCCURRED. TYPE OF INTERVENTION: A NEW DEVICE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14581663 ↗
• MalfunctionOct 27, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSCOPIC SIGMARESECTION. EVENT DESCRIPTION: THE SHEATH OF THE ALEXIS TORE WHEN THE DOCTOR TRIED TO PUT THE CAP ON. NO ONE COULD SEE WHY THIS HAPPENED. I WAS THERE FOR THE SURGERY AND COULDN'T SEE IT EITHER. I CLEANED THE PRODUCT AND TOOK PICTURES. THE HOSPITAL KEPT THE PRODUCT THERE - IN CASE FOR INVESTIGATION. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6)2021: NEITHER THE REPRESENTATIVE NOR THE SURGEON NOTICED ANY INSTRUMENT COMING INTO CONTACT WITH THE SHEATH. THE CUSTOMER USES THIS DEVICE ON A NEAR DAILY BASIS, BUT THEY NEVER EXPERIENCED A DAMAGED SHEATH. TYPE OF INTERVENTION: NI. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704464 ↗
• MalfunctionMar 20, 2020Material Separation; Material Separation

  NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: ALL FROM MEDICAL LEADERS INCOMING INSPECTION (B)(4): C8501 - TEAR IN DUCKBILL. PATIENT STATUS: NA. TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 9861243 ↗
• MalfunctionFeb 5, 2020Material Separation; Material Separation

  NAME OF PROCEDURE BEING PERFORMED: UNKNOWN. DETAILED DESCRIPTION OF EVENT: HOSPITAL: [NAME]. "THE VALVE PART BROKE DOWN AND DROPPED OFF FROM THE CENTER OF THE CAP, WHEN THE SURGEON INSERTED THE 12 MM KII TROCKER INTO THE CAP DURING THE TREATMENT. AS WE CHECKED THE ACTUAL PRODUCT, IT WAS BROKEN." [NAME] HAS TWO QUESTIONS AS BELOW: HAVE YOU HAD THE SAME PRODUCT IMPERFECTION ON THE SAME LOT#1361261? IF YOU HAD BEFORE, WOULD YOU PROVIDE US THE CAUSE AND EFFECT?" PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION NO INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673919 ↗
• MalfunctionSep 5, 2017Material Perforation; Material Perforation

  ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM SALES MANAGER ON TUESDAY AUGUST 29, 2017: - AT WHAT POINT DURING THE CASE DID THE SURGEON/STAFF REALIZE THE SHEATH WAS TORN? DURING THE SURGERY, AFTER BEING INSERTED TO THE PATIENT BODY. - WAS THE CAP ON THE PRODUCT WHEN THE SURGEON/STAFF REALIZED THE SHEATH WAS TORN? NO. THERE WAS NO DAMAGE ON THE CAP. - DID ANY INSTRUMENTATION COME IN CONTACT WITH THE SHEATH? IF SO, WAS THE INSTRUMENTATION BEING PLACED THROUGH A TROCAR THROUGH THE CAP? COMMON LAPAROSCOPIC INSTRUMENTS WERE USED THROUGH THE TROCAR ON THE CAP. - DID THE SHEATH PARTICULATE? YES. SHEATH PARTICULATED. - WAS ALL MATERIAL RETRIEVED YES. RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6843986 ↗
• MalfunctionJun 23, 2017Material Perforation; Material Perforation

  LAP. PROXIMAL GASTRECTOMY - "SHEATH WAS TORN DURING THE SURGERY". TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY OR RELATED ILLNESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664697 ↗
• MalfunctionSep 13, 2016Packaging Problem; Packaging Problem

  "PACKAGE NOT SEALED." ADDITIONAL INFORMATION RECEIVED: THE PRODUCT WAS KEPT ON THE SHELVING IN THE PRODUCT BOX. NO DAMAGE WAS NOTED ON THE BOX THE PRODUCT WAS TAKEN OUT OF. NO OTHER PRODUCTS IN THE BOX SHOWED SIGNS OF DAMAGE. PATIENT STATUS: UNKNOWN .

  Patient problems: No Patient Involvement

  MAUDE report 5946240 ↗