Alexis Laparoscopic System With Kii Fios First Entry C8701Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00607915125714), received between Nov 14, 2016 and Jun 30, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC ASSISTED LAPAROSCOPIC ESOPHAGESCTOMY. EVENT DESCRIPTION: USED FOR ROBOTIC CASE. SURGERY PAUSED TO RETRIEVE THE INSTRUMENT SEAL FROM TROCAR. IN THE MID OF ROBOTIC SURGERY, AFTER INSTRUMENT EXCHANGE. NO ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION OBTAINED FROM APPLIED MEDICAL ACCOUNT MANAGER VIA EMAIL ON 24JUN2025: GRASPER AND SUCTION CATHETER WERE USED DURING THE PROCEDURE. INTERVENTION: NO REPLACEMENT OF TROCAR WAS USED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366675 ↗
• MalfunctionOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC LOWER ANTERIOR RESECTION. EVENT DESCRIPTION: THE EVENT OCCURRED DURING TREATMENT OF AN UNKNOWN PROCEDURE. IT WAS NOT REPORTED HOW THE DEVICE WAS BEING USED OR WHAT ACTION WAS BEING PERFORMED WHEN THE EVENT OCCURRED. THE DUCK BILL SEAL FELL OUT INTO PATIENT. THE SEAL WAS REMOVED. THE SURGEON RESOLVED THE SITUATION BY REMOVING THE SEAL FROM THE PATIENT. IT WAS NOT REPORTED IF OTHER INSTRUMENTS WERE USED WHEN THE COMPLAINT EVENT OCCURRED. IT IS UNKNOWN IF THERE WAS ANY CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. THERE IS NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THE COMPLAINT EVENT. THE PATIENT STATUS IS STABLE. ADDITIONAL INFORMATION WAS RECEIVED FROM FIELD TEAM MEMBER ON OCTOBER 25, 2023: NAME OF THE PROCEDURE PERFORMED: LAPAROSCOPIC LOWER ANTERIOR RESECTION. DATE OF THE EVENT: (B)(6) 2023. SEAL FELL OUT AS GRASPER WAS INSERTED INTO PORT. SURGEON WAS ABLE TO RETRIEVE FULL SEAL FROM PATIENT AND EXAMINED FOR ANY FRAGMENTS MISSING. FULL SEAL INTACT. NO CLINICAL IMPACT TO PATIENT, AND SURGEON WAS CONFIDENT THAT THIS HAS NEVER PREVIOUSLY HAPPENED, AND THAT PATIENT WAS STABLE. OTHER INSTRUMENT BEING USED WHEN THE COMPLAINT EVENT OCCURRED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039940 ↗
• MalfunctionMay 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: SUBTOTAL GASTRECTOMY. EVENT DESCRIPTION: [TRANSLATION] DURING A ROBOTIC SURGERY, A PART OF THE TROCAR THAT THEY WERE MOVING CAME OFF AND A PIECE FELL INSIDE THE PATIENT'S ABDOMEN. NO ONE EXPLAINS WHY IT HAPPENED. NOTHING HAS BEEN FORCED AND THE TEAM OF PROFESSIONALS IS USED TO MAKING THIS KIND OF CHANGE HAPPEN. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 23MAY23: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. THE PATIENT IS OK. THE EVENT OCCURRED ON (B)(6) 2023. NAME OF PROCEDURE BEING PERFORMED IS SUBTOTAL GASTRECTOMY. THE SITUATION WAS RESOLVED BY REMOVING THE PIECE FROM THE PATIENT'S ABDOMEN WITH A GRASPING FORCEPS. WITHOUT ANY DIFFICULTY. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE CUSTOMER DOES NOT KNOW WHAT INSTRUMENT WAS BEING USED AT THE TIME IT CAME OFF, AS THEY DID NOT SEE IT FALL OUT AT ANY TIME. IT WAS FOUND WHEN CHECKING THE ABDOMINAL CAVITY. IT IS UNKNOWN WHAT OTHER INSTRUMENTS WERE USED PRIOR TO THE INCIDENT. NO SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT, ONLY THE PART SHOWN IN THE PICTURE. TYPE OF INTERVENTION: THE SITUATION WAS RESOLVED BY REMOVING THE PIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027828 ↗
• MalfunctionApr 22, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC SIGMOID COLECTOMY. EVENT DESCRIPTION: "THE DISTAL END OF TROCAR BROKE OFF WHEN INSTRUMENT PLACED PRESSURE ON IT.  THE BROKEN PIECE WAS RETRIEVED AND REMOVED." AFTER SPEAKING WITH, INITIAL REPORTER, SHE MENTIONED THAT NOT ALL PLASTIC PIECES WERE ABLE TO BE REMOVED. "STAPLER WAS BEING USED AT THE TIME THE TROCAR BROKE."  ALSO, PER THE OP NOTE "A PORTION OF THE 12 MM PORT BROKE OFF INSIDE THE PATIENT DURING THE CASE. THE LARGEST PORTION OF THIS WAS REMOVED HOWEVER SMALLER PIECE WAS NEVER IDENTIFIED AFTER CONSIDERABLE TIME AND EFFORT WAS DEDICATED TO LOCATING THIS SMALL, LIKELY LESS THAN 5 MM PIECE OF PLASTIC." ADDITIONAL INFORMATION RECEIVED VIA EMAIL 13APR2022 FROM APPLIED MEDICAL REPRESENTATIVE: FIELD TEAM IS UNSURE OF THE CURRENT PATIENT STATUS. IT IS UNKNOWN HOW THE TROCAR WAS INSERTED OR IF IT WAS BROKEN UPON ENTRY OR NOT. THE BREAK WAS NOT CLEAN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 14APR2022 FROM USER FACILITY: PATIENT WAS DISCHARGED HOME ON (B)(6) 2022. THE DOCTOR PUT THE TROCARS IN WITH A TWISTING MOTION. THERE WAS NO DIFFICULTY DURING INSERTION. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: THE LARGEST PORTION OF BREAK WAS REMOVED. PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190925 ↗
• MalfunctionAug 5, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: UROLOGICAL PROCEDURE DETAILED DESCRIPTION OF EVENT: CER 1 OF 2: (B)(4), CER 2 OF 2: (B)(4). WHEN INSERTING THE ALEXIS, THE PRODUCT WAS UNDAMAGED. AFTER REMOVING THE CAP LATER, A TEAR WAS FOUND IN THE SHEATH. ACCORDING TO THE CUSTOMER, THIS HAPPENED ONCE BEFORE ON (B)(6) 2021 WITH A PRODUCT FROM THE SAME LOT#. NONE OF THE PRODUCTS WERE KEPT FOR INVESTIGATION. THE FIRST TIME THE TEAR WAS ALONG FROM THE GREEN PLACEMENT RING ABOUT 7CM TOWARDS THE WHITE RING, THEN THE SECOND TIME ALONG THE GREEN RING (CIRCULAR). THE CUSTOMER CANNOT EXPLAIN HOW AND WHEN THE TEARING OCCURRED, WHETHER IT WAS A USER ERROR OR PRODUCT DEFECT. HE SAYS IT COULD BE THAT THE WHITE RING WAS ROLLED IN TOO MANY TIMES TO CREATE MAXIMUM RETRACTION. AFTER CONSULTATION, THE PRODUCT WAS PROPERLY APPLIED FOR AN INCISION SIZE BETWEEN 2.5-6CM. THEY NEEDED TO REPLACE THE PRODUCT FOR THIS PROCEDURE. THE PATIENT WAS OK. PATIENT STATUS: GOOD, NO CONSEQUENCES FOR THE PATIENT. TYPE OF INTERVENTION: CHANGE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281804 ↗
• MalfunctionAug 5, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: UROLOGICAL PROCEDURE. DETAILED DESCRIPTION OF EVENT: CER 1 OF 2: (B)(4). CER 2 OF 2: (B)(4). WHEN INSERTING THE ALEXIS, THE PRODUCT WAS UNDAMAGED. AFTER REMOVING THE CAP LATER, A TEAR WAS FOUND IN THE SHEATH. ACCORDING TO THE CUSTOMER, THIS HAPPENED ONCE BEFORE ON (B)(6) 2021 WITH A PRODUCT FROM THE SAME LOT#. NONE OF THE PRODUCTS WERE KEPT FOR INVESTIGATION. THE FIRST TIME THE TEAR WAS ALONG FROM THE GREEN PLACEMENT RING ABOUT 7CM TOWARDS THE WHITE RING, THEN THE SECOND TIME ALONG THE GREEN RING (CIRCULAR). THE CUSTOMER CANNOT EXPLAIN HOW AND WHEN THE TEARING OCCURRED, WHETHER IT WAS A USER ERROR OR PRODUCT DEFECT. HE SAYS IT COULD BE THAT THE WHITE RING WAS ROLLED IN TOO MANY TIMES TO CREATE MAXIMUM RETRACTION. AFTER CONSULTATION, THE PRODUCT WAS PROPERLY APPLIED FOR AN INCISION SIZE BETWEEN 2.5-6CM. THEY NEEDED TO REPLACE THE PRODUCT FOR THIS PROCEDURE. THE PATIENT WAS OK. PATIENT STATUS: GOOD, NO CONSEQUENCES FOR THE PATIENT. TYPE OF INTERVENTION: CHANGE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281787 ↗
• MalfunctionJan 15, 2020Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN LAPAROSCOPIC SURGERY. EVENT DESCRIPTION: A PIECE OF A BLACK PLASTIC PART OF THE SEAL FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED. THE SURGEON WAS USING A GRASPER AT THE TIME THE INCIDENT WAS NOTED. THE SAFETY OFFICER AT THE HOSPITAL STATED THAT A REPORT WAS SENT TO THE FDA. LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. THE MODEL AND LOT NUMBER IS UNKNOWN. THE PROCEDURE IS UNKNOWN. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 05DEC2019 FROM CLINICAL COORDIN: A PIECE OF THE TROCAR WAS TORN APART. ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 23DEC2019 FROM FDA MEDWATCH PROGRAM: REPORT# MW5091514. REPORTER: [NAME] RISK MANAGER: EVENT DATE: (B)(6) 2019. EVENT REPORT TYPE: SERIOUS INJURY. EVENT OUTCOME: REQUIRED INTERVENTION. MODEL: C8701. LOT# 1369677. EVENT DESCRIPTION: THE ALEXIS LAPAROSCOPIC SYSTEM WITH KII FIOS FIRST ENTRY HAD A RUBBER PIECE BREAK OFF AND WAS INSIDE THE PATIENT. SURGEON WAS ABLE TO RETRIEVE RUBBER PIECE FROM TORCHER WITHIN SET. FDA SAFETY REPORT ID # (B)(4). PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593690 ↗
• MalfunctionJan 14, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 1 OF 2. COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 2 OF 2. THIS WAS DISCOVERED PRIOR TO SURGERY AND THERE WAS NO PATIENT CONTACT. WHEN THE DEVICE WAS PULLED FROM THE SHELF IT WAS NOTED THAT A PINHOLE WAS ON THE WHITE TYVEK SIDE OF THE POUCH ON EACH OF THE UNITS PULLED. IT IS UNKNOWN IF THE SAME LOT WAS PULLED FOR BOTH DEVICES. ONCE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT AVAILABLE FOR RETURN. THE OTHER UNIT IS AVAILABLE FOR RETURN. THE HOSPITAL HAS THIRD PARTY SOURCING WITHIN THE HOSPITAL AND THE DEVICES ARE REMOVED FROM THE OUTER CARTON AND PLACED ON THE SHELF BY MEDICAL STAFF FOR STORAGE. PHOTOGRAPHS ARE AVAILABLE ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 19DEC2019 FROM APP. MED. ACCT. MGR.: 6 PHOTOS WERE PROVIDED. THE HOSPITAL IS [NAME] HOSPITAL ACCOUNT # (B)(6). PRODUCT: ALEXIS LAPAROSCOPIC SYSTEM (SMALL). 1 EACH OF PRODUCT # C8701, # LOT # 1338150. 1 EACH OF PRODUCT # C8701, # LOT # 1335750 PATIENT STATUS: NA (BEFORE USE). TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 9589270 ↗
• MalfunctionJan 14, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 1 OF 2. COMPLAINT (B)(4) WILL ADDRESS EVENT UNIT 2 OF 2. THIS WAS DISCOVERED PRIOR TO SURGERY AND THERE WAS NO PATIENT CONTACT. WHEN THE DEVICE WAS PULLED FROM THE SHELF IT WAS NOTED THAT A PINHOLE WAS ON THE WHITE TYVEK SIDE OF THE POUCH ON EACH OF THE UNITS PULLED. IT IS UNKNOWN IF THE SAME LOT WAS PULLED FOR BOTH DEVICES. ONCE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT AVAILABLE FOR RETURN. THE OTHER UNIT IS AVAILABLE FOR RETURN. THE HOSPITAL HAS THIRD PARTY SOURCING WITHIN THE HOSPITAL AND THE DEVICES ARE REMOVED FROM THE OUTER CARTON AND PLACED ON THE SHELF BY MEDICAL STAFF FOR STORAGE. PHOTOGRAPHS ARE AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 19DEC2019 FROM APP. MED. ACCT. MGR.: 6 PHOTOS WERE PROVIDED THE HOSPITAL IS [NAME] HOSPITAL ACCOUNT # (B)(4). PRODUCT: ALEXIS LAPAROSCOPIC SYSTEM (SMALL). 1 EACH OF PRODUCT # C8701, # LOT # 1338150. 1 EACH OF PRODUCT # C8701, # LOT # 1335750. PATIENT STATUS: NA (BEFORE USE). TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 9589095 ↗
• MalfunctionMay 15, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: PROSTATECTOMY DA VINCI. DETAILED DESCRIPTION OF EVENT: AFTER RETRIEVING THE PROSTATE, THE CAP WAS PLACED ON THE ALEXIS, THE CTF71 INSERTED AND INSUFFLATED. THE PATIENT WAS SUFFICIENTLY RELAXED ACCORDING TO [NAME] AND DID NOT PRESS. AFTER A SHORT MOMENT, THERE WAS A BANG, THE CAP FLEW OFF, INTESTINAL LOOPS BULGED OUT OF THE INCISION AND THE FOIL OF ALEXIS WAS DAMAGED. THE OPTIC HAD NOT BEEN INTRODUCED AT THIS TIME. THE GENERAL SURGEONS WERE CONSULTED AND AFTER INSPECTING THE BOWELS THEIR COULD NOT FIND ANY INJURIES. [NAME] HIMSELF WAS NOT IN THE ROOM DURING THE PROCEDURE. I WILL BE THERE TOMORROW MORNING AND SPEAK WITH THE DIRECTLY INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE BY EMAIL ON 01MAY2019: I TALKED TO THE INVOLVED PEOPLE IN THE MEANTIME AND THEY DESCRIBED THE EVENT AS FOLLOWS: AFTER THE FASCIA SUTURES WERE APPLIED, THE ALEXIS WAS INSERTED INTO THE INCISION AT THE BEGINNING OF THE PROCEDURE. THE CAP WAS PLACED ON THE ALEXIS, THE DA VINCI METAL TROCAR INTRODUCED AND INSUFFLATED. AFTER A SHORT MOMENT THERE WAS A LOUD BANG AND THE INTESTINAL LOOPS BULGED LATERALLY THROUGH THE CRACK IN THE FOIL. THE CAP REMAINED ON THE OU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8614028 ↗
• MalfunctionOct 9, 2017Break; Break

  PROCEDURE PERFORMED : UNKNOWN EVENT DESCRIPTION: "NOTICED THAT A PIECE OF CANNULA WAS BROKEN OFF BUT WAS ABLE TO RETRIEVE FROM THE PATIENT'S ABDOMEN. THE PATIENT WAS OF LARGE SIZE, AND A LOT OF TORQUE WAS NEEDED FOR THE LAPAROSCOPIC INSTRUMENTS WHEN THE CANNULA CLEANLY BROKE." ADDITIONAL INFORMATION WAS RECEIVED HEALTH SYSTEMS MANAGER VIA EMAIL ON THURSDAY, SEPTEMBER 21, 2017: "A PIECE OF THE TIP BROKE OFF. I AM STILL ATTEMPTING TO FIND OUT IF THIS WAS WHILE INSERTED WITHIN THE ALEXIS LAP CAP OR WITHIN THE PATIENT'S ABDOMEN. I AM ATTEMPTING TO FIND OUT WHAT INSTRUMENT WAS INSERTED THROUGH THE TROCAR WHEN IT EXPERIENCES A BREAK." TYPE OF INTERVENTION: "UNKNOWN." PATIENT STATUS: "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6930958 ↗
• MalfunctionMay 25, 2017Material Perforation; Material Perforation

  LAPAROSCOPIC SIGMOID COLON RESECTION - "PRESSURE SETTING AT INSUFFLATION SET AT 14. PATIENT BUCKED AND THE ALEXIS BLOW OUT...THE SHEALTH SPLIT. USED SECOND UNIT AND IT HAPPENED AGAIN....SAME LOT NUMBER. ALSO SENDING ONE UNIT OF STERILE PRODUCT FROM SAME LOT NUMBER." TYPE OF INTERVENTION - NA. PATIENT STATUS - NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591461 ↗
• MalfunctionMay 25, 2017Material Perforation; Material Perforation

  LAPRASCOPIC SIGMOID COLON RESECTION - "PRESSURE SETTING AT INSULFLATION SET AT 14. PATIENT BUCKED AND THE ALEXIS BLOW OUT...THE SHEALTH SPLIT. USED SECOND UNIT AND IT HAPPENED AGAIN....SAME LOT NUMBER. ALSO SENDING ONE UNIT OF STERILE PRODUCT FROM SAME LOT NUMBER." TYPE OF INTERVENTION - NA PATIENT STATUS - NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591457 ↗
• MalfunctionApr 4, 2017Material Perforation; Material Perforation

  RADICAL PROSTATECTOMIZED VINCI - OBVIOUSLY THE ANESTHESIA (RELAXATION) WAS TO LOW THAT THE MUSCLE CONTRACTION OF THE PATIENT WAS HIGHER, THIS LET TO THE FACT THAT THE INTRA ABDOMINAL PRESSURE INCREASE ENORMOUS. AS THE CONSEQUENCE THE SHAFT OF THE ALS TORE AND THE CAP OF THE SYSTEM POPPED OFF WITH AN EXTREME LOUD SOUND. PATIENT IS FINE. THE TROCARS HAD TO BE REPLACED WITH A MINIMAL ELONGATION OF THE PROCEDURE TIME. ADDITIONAL INFORMATION RECEIVED FROM (B)(4) MARCH 16 2017: AFTER THE CAP BLEW OFF, THERE WAS RAPID LOSS OF PNEUMOPERITONEUM. THE INCIDENT OCCURRED DURING THE PROCEDURE, SO INSTRUMENTS WERE BEING PASSED THROUGH WHEN THIS HAPPENED. THERE WERE DAVINCI INSTRUMENTS IN USE. WHEN THE CAP POPPED OFF, THEY IMMEDIATELY REMOVED THE ARMS OF THE DAVINCI ADDITIONAL INFORMATION RECEIVED FROM (B)(4) ON 24 MARCH 2017: THERE WAS A TROCAR INSERTED THROUGH THE CAP, THE 12 MM KII FIOS Z-THREAD THAT IS INCLUDED WITH THE ALEXIS LAP. 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 6456926 ↗
• MalfunctionMar 4, 2017Break; Break

  ROBOTIC LAPAROSCOPIC PROSTATECTOMY- "NURSE (B)(6) IN THE ROOM STATED THAT THE TROCAR THAT WAS USED FOR THE CAMERA WAS LEAKING PNEUMO. ONCE THEY REMOVED THE TROCAR, THEY NOTICED THE CRACK IN THE SIDES AND REPLACED WITH ANOTHER SINGLE UNIT TROCAR. DR. TEWARI MENTIONED TO THE NURSE THAT IT HAPPENED TWICE PRIOR BUT NO SPECIFIC DATE." PATIENT STATUS - "PATIENT WAS FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6378852 ↗
• MalfunctionNov 14, 2016Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED - UNKNOWN: - "THE CONSULTANT DURING THE CASE "NOTICED A BLACK FRAGMENT IN THE ABDOMEN. THE SURGEON WAS USING AN ENDORACTOR THROUGH THE PORT AT THE TIME. THE PORT WAS REMOVED AND ON INSPECTION IT LOOKED LIKE A PART OF THE SEAL WAS MISSING." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON (B)(6) 2016: "AN ENDORACTOR WHICH WAS USED TO PACK THE SMALL BOWEL AWAY FROM THE OPERATING FIELD WAS INSERTED THROUGH THE PORT. IT WAS AFTER THIS THAT THE SURGEON NOTICED A SMALL BLACK FRAGMENT IN THE PATIENT. THIS WAS THEN REMOVED FROM THE PATIENT, THE TROCAR WAS REPLACED AND PROCEDURE COMPLETED." PATIENT STATUS: "NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6100992 ↗