Alexis Contained Extraction System with Kii Balloon Blunt Tip System GTK17Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 20607915134826), received between Mar 8, 2016 and Aug 25, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Break

  Patient problems: Bowel Perforation

  MAUDE report 50442180 ↗
• MalfunctionJun 12, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC TOTAL HYSTERECTOMY EVENT DESCRIPTION: THE COMPLAINT WAS GENERATED FROM MEDSUN UF/IMPORTER REPORT # (B)(4) RECEIVED ON 15MAY2026 (B)(6) GTK17 WAS USED IN THE VAGINA TO REMOVE THE SPECIMEN. WHEN THE ALEXIS RETRACTOR WAS REMOVED IT WAS NOTED IT HAD A SMALL TEAR IN THE THIN PLASTIC LINING. THE ENTIRE SURGICAL TEAM INSPECTED THE ALEXIS AND ALL AGREED THE BAG APPEARED TO NOT BE MISSING ANY OF THE PLASTIC. A SEARCH OF THE VAGINA AND ABDOMEN WAS PERFORMED BY ALL SURGICAL TEAM MEMBERS, AND NO PLASTIC PARTS WERE OBSERVED. THE SPECIMEN WAS ALSO SEARCHED BEFORE BEING SENT TO PATHOLOGY. ALL TEAM MEMBERS AGREE THE BAG WAS TORN AND LIKELY STRETCHED DURING REMOVAL FROM THE VAGINA. ADDITIONAL INFORMATION PROVIDED BY [NAME] VIA EMAIL ON 19MAY2026: LOT # OF THE DEVICE IS UNKNOWN. THE TEAR WAS LOCATED ON THE PLASTIC BAG. NO PICTURE AVAILABLE. THE UTERINE TISSUE WAS BEING REMOVED WITH LARGE FIBROIDS. THERE WAS NO SPILLAGE OUT OF THE DAMAGE ON THE BAG. THE DEVICE WAS USED VAGINALLY AND THE SPECIMEN WAS REMOVED VAGINALLY. NO INSTRUMENTS WERE USED TO PLACE THE BAG INTO THE PATIENT. INTERVENTION: PATIENT CAVITY, SPECIMEN SEARCHED FOR PIECES OF PLASTIC. NONE FOUND. PATIENT STATU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494269 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC TOTAL HYSTERECTOMY. EVENT DESCRIPTION: TAB CAME OFF AND ENDED UP IN PATIENT'S ABDOMEN. PIECE WAS RETRIEVED SUCCESSFULLY. JUST ONE PIECE CAME OFF THE OUTER RING. ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER VIA EMAIL ON 11DEC2025: I HAVE BEEN WORKING ON GATHERING MORE INFORMATION. I GOT SOME MORE INTEL BUT AM STILL WORKING TO ANSWER SOME OF YOUR QUESTIONS. LOT #1550567 TAB WAS LOCATED INSIDE THE PATIENT¿S BODY. CASE ¿ ROBOTIC TOTAL HYSTERECTOMY. I WILL LET YOU KNOW ONCE I HEAR BACK FROM MY CONTACT. ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER VIA EMAIL ON 15DEC2025: I HAVE ATTACHED TWO PICTURES OF THE ALEXIS CONTAINED EXTRACTION SYSTEM THAT HAD A TAB BREAK WHICH CAN BE SEEN IN THE PHOTOS. THE SURGEON WHO HAD THIS ISSUE HAS NOT REPLIED TO EMAILS BUT IS IN THE OR THIS WEEK. MY CONTACT IS GOING TO SPEAK WITH THEM TO GET MORE DETAILS TO BETTER ANSWER YOUR QUESTIONS. INTERVENTION: RETRIEVED PIECE OUT OF PATIENT. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883008 ↗
• MalfunctionNov 21, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LEFT NEPHRECTOMY. EVENT DESCRIPTION: MEDWATCH FORM FDA-3500A #2201630000-2025-8051. PT PROCEDURE LEFT NEPHRECTOMY. KIDNEY WAS PLACED IN AN ALEXIS CONTAINED EXTRACTION SYSTEM, LOT 1565072, EXP 05/27/28. 2 PIECES BROKE OFF FROM THE BAG WHEN REMOVING THE KIDNEY THROUGH THE ABDOMEN. 2 PIECES RETRIEVED. SURGEON VERIFIED THROUGH OPEN INCISION EXPLORATION & VIA LAPAROSCOPY. NO RETAINED PIECES SEEN. SUPPLY IS NO RADIO OPAQUE. ADDITIONAL INFORMATION PROVIDED BY [NAME]ON 24OCT2025 VIA EMAIL: NO PATIENT INJURY. PATIENT'S STATUS IS DISCHARGED. EVENT DATE IS 9/15/25. UNFORTUNATELY THE STAFF DID NOT SAVE IT (THE DEVICE). IT WAS THE SPECIMEN CONTAINMENT BAG PART THAT RIPPED AND PIECES FELL OFF. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 24OCT2025: THE ORIENTATION OF THE BAG INSIDE THE PATIENT¿S BODY WAS RIGHT SIDE UP-WITH THE OPENING FACING THE CEILING. I DON¿T RECALL IF THE BAG WAS FAN FOLDED OR ROLLED. I DON'T THINK I UNDERSTAND THIS BUT THE BAG WAS FULLY OPEN/DEPLOYED. INTERVENTION: 2 PIECES RETRIEVED. NO RETAINED PIECES SEEN. PATIENT STATUS: NO PATIENT INJURY INDICATED. DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621397 ↗
• MalfunctionAug 14, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: KIDNEY REMOVAL. EVENT DESCRIPTION: WHEN REMOVING THE PATIENT¿S KIDNEY AN ALEXIS BAG RETRIEVAL SYSTEM WAS USED. WHEN REMOVING THIS BAG WITH THE KIDNEY INSIDE, THE BAG WAS PULLED TOO HARD, AND THE BAG BROKE INSIDE THE BODY. THE BAG WAS PLACED ON THE BACK TABLE AND THE KIDNEY WAS REMOVED BY HAND. THE CAVITY WAS THEN SWEPT, AND 2 MORE SMALL PIECES OF THE BAG RETRIEVAL SYSTEM WERE FOUND AND REMOVED. THE ROBOT WAS THEN REDOCKED TO FIND THE MISSING LYMPH NODE SPECIMEN. WHILE DOCKED THE CAVITY WAS SWEPT AGAIN AND NO MORE PIECES OF THE BAG RETRIEVAL SYSTEM WERE FOUND. EVENT DATE: 7/7/2025. SYSTEM EXTRACTION ALEXIS CONTAINED 12X100MM BALLOON BLUNT MFG # GTK17 SAMPLE AVAILABLE: NO. LOT # UNKNOWN. WAS THERE INJURY? NO, BUT PRODUCT ERROR RESULTED IN THE NEED FOR INCREASED MONITORING THERE ARE NO SAMPLES AVAILABLE. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 16JUL2025 VIA EMAIL: IT TORE IN THE CORNER WHILE PULLING OUT THE SPECIMEN. NOTHING WAS USED INSIDE THE BAG OTHER THAN TO GRASP THE SPECIMEN AND PLACE IT INSIDE THE BAG. INTERVENTION: THE BAG WAS PLACED ON THE BACK TABLE AND THE KIDNEY WAS REMOVED BY HAND. PATIENT STATUS: NO INJURY, BUT PRODUCT ERROR RESULTED IN THE NEED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806929 ↗
• MalfunctionJun 25, 2025Defective Device

  INITIAL BALLOON WAS DEFECTIVE REQUIRING OPERATING TEAM MEMBER TO OBTAIN A NEW ONE AND THIS ONE WORKED FINE.. NO ADVERSE PROBLEMS FOR THE PATIENT RESULTED WITH THE DEFECTIVE BALLOON. THE SALES REPRESENTATIVE WAS CONTACTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327013 ↗
• MalfunctionNov 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: MYOMECTOMY. DESCRIPTION OF EVENT: [NAME] AND I HAD A CALL WITH DR. [NAME], AN OBGYN FELLOW AT [NAME] IN LOS ANGELES, CA, YESTERDAY TO DISCUSS HER EXPERIENCE USING THE ALEXIS CES. SHE RELAYED THAT LAST WEEK HER TEAM WAS PERFORMING A MYOMECTOMY AND WHEN EXTERIORIZING AN ~250-500G SPECIMEN IN THE CES, THE BAG TORE. SHE SAID THEY HAD EXTERIORIZED THE MAJORITY OF THE CES BAG'S OUTER RING AND THEN SHE EXPERIENCED RESISTANCE, SO SHE USED MORE FORCE TO TRY TO EXTERIORIZE THE REMAINDER OF THE RING. THE BAG ENDED UP TEARING ABOUT 1/3RD OF THE WAY DOWN FROM THIS FORCE. THEY WERE ABLE TO PULL THE FULL RING OUT AND PULL ENOUGH OF THE SHEATH OUT THAT THE TEAR WAS EXTERIORIZED AS WELL. THEY ROLLED DOWN THE OUTER RING PAST THIS TEAR AND PROCEEDED WITH THE MORCELLATION. THEY HAD NO FURTHER ISSUES AND THE PATIENT DID WELL. THE SURGEON WAS NOT SURE WHICH CES MODEL SHE WAS USING. INTERVENTION: THEY ROLLED DOWN THE OUTER RING PAST THIS TEAR AND PROCEEDED WITH THE MORCELLATION. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645447 ↗
• MalfunctionMar 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: ROBO HYSTERECTOMY/BSO/SLN DISSECTION AND LYSIS OF ADHESIONS. MEDWATCH REPORT # (B)(4): "DESCRIBE THE EVENT OR PROBLEM: SURGICAL HYSTERECTOMY FOR PATIENT WITH EARLY STAGE ENDOMETRIAL CANCER USING ALEXIS CONTAINED EXTRACTION SYSTEM FOR REMOVAL OF UTERUS. THE BAG APPARENTLY BROKE WITH MORCELLATED PIECES OF UTERUS SPILLING. THOUGH RISK DEEMED LOW FOR INTRA-PERITONEAL SPREAD, THERE IS NO WAY TO BE SURE. IN LIGHT OF THAT, DECISION WAS MADE TO ADD VAGINAL BRACHYTHERAPY (RADIATION) TO TREATMENT PLAN, WHICH WAS NOT PART OF THE INITIAL TREATMENT PLAN. EXAMINATION OF THE BAG REVEALS THE AREA THAT BROKE APPEARS TO INDICATE STRETCHING AT THE SEAM." THE ORIGINAL INTENDED PROCEDURE: "ROBO HYSTERECTOMY/BSO/SLN DISSECTION AND LYSIS OF ADHESIONS." EVENT DATE: (B)(6) 2019 ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 22APR2019 FROM DIR. RISK MGMT. HOSP: YES, INSTRUMENTS WERE USED TO PLACE THE BAG INTO THE PATIENT. "PLACED IN VAGINALLY, AND THEN I THINK THE ROBOTIC INSTRUMENTS WERE USED TO HELP BRING IT OVER THE UTERUS." ROBOTIC FENESTRATED BIPOLAR AND CADIER WERE IN USE WHEN PLACING THE SPECIMEN INTO THE BAG. SHARP INSTRUMENTS DID NOT COME INTO CONTACT WITH THE B

  Patient problems: Injury

  MAUDE report 8452717 ↗
• MalfunctionApr 13, 2018Material Perforation; Material Perforation

  PROCEDURE PERFORMED: SUBTOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMIES. EVENT DESCRIPTION: "SURGEON HAD PLACED UTERUS IN THE ALEXIS CES BAG AND HAD PULLED BAG TO THE OUTSIDE OF THE ABDOMEN. AFTER PULLING WHITE RING OF ALEXIS CES, HAD CHECKED TO SEE THE LOCATION OF THE SPECIMEN BEFORE ROLLING THE RING OF THE ALEXIS CES AND HAD NOTICED THAT SPECIMEN WAS NOT IN BAG. HAD PUT THE SCOPE INTO THE ABDOMEN, HAD NOTICED THAT SPECIMEN HAD FALLEN OUT OF THE BAG. WHEN PULLED THE ALEXIS CES OUT FROM THE ABDOMEN, THERE WAS A HOLE AT THE BOTTOM OF THE BAG." ADDITIONAL INFORMATION RECEIVED ON MARCH 26, 2018: "I SPOKE TO THE TM WHO ATTENDED THE CASE. SHE SAID THAT THE SCRUB NURSE FOLDED THE ALEXIS CES AND DID NOT NOTICE THE HOLE/TEAR. THE BAG WAS NOT SPECIFICALLY INSPECTED FOR TEARS. THE SPECIMEN WAS MEASURE 2 WEEKS PRIOR TO THE CASE AS 12 X 11 X 8CM. AFTER THE INCIDENT, THE SPECIMEN WAS ABLE TO BE PLACED INTO A GTB14." TYPE OF INTERVENTION: UNK. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429789 ↗
• MalfunctionNov 2, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED- "FIBROID REMOVAL" (B)(4). "CONTAINED EXTRACTION SYSTEM WAS BEING USED TO RETAIN UTERINE FIBROIDS WHICH WERE REMOVED FROM PATIENT'S UTERUS. ON REMOVAL OF THE EXTRACTION SYSTEM, THE BAG BROKE. A SMALL PIECE OF BAG WAS FOUND ON THE STERILE FIELD. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING?" ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON OCTOBER 11. 2017 FROM THE RISK MANAGER AT (B)(6). "UNFORTUNATELY, ALL OF THE INFORMATION I HAD WAS SUBMITTED IN THE MEDWATCH REPORT. I DO NOT HAVE ANYTHING FURTHER TO ADD." TYPE OF INTERVENTION - "THE PROCEDURE WAS COMPLETED WITH NO HARM TO PATIENT. PATIENT STATUS - "NO HARM TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6997002 ↗
• MalfunctionMar 1, 2017Material Perforation; Material Perforation

  VATS LOBECTOMY - "SURGEON PLACED DEVICE INTO THORACIC CAVITY. SURGEON PLACED SPECIMEN IN THE DEVICE. SURGEON REMOVED WHITE RING OF DEVICE FROM THE THORACIC CAVITY, AND PROCEEDED TO PULL THE DEVICE. DEVICE SPLIT ALONG BOTTOM SEEM WHILST SURGEON WAS PULLING THE DEVICE. DEVICE WAS REMOVED, AND SPECIMEN THEN REMOVED USING FORCEPS" . INTERVENTION - "UNKNOWN". PATIENT STATUS - "NO COMPLICATIONS".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6368590 ↗
• MalfunctionNov 16, 2016Material Perforation; Material Perforation

  PROCEDURE PERFORMED UNKNOWN - "UTERUS WAS PLACED IN ALEXIS CES BAG AND THE BAG RING WAS EXTRACTED THROUGH THE UMBILICAL INCISION. INCISION WAS ENLARGED WITH SCISSOR AND COLD KNIFE WITH THE BAG IN PLACE. BAG SHOWED THREE HOLES UPON TESTING WITH WATER POST PROCEDURE. MORCELLATION WAS UNDER DIRECT VISUALIZATION. GUARD SHOWED SMALL CUT ON THE OUTER RIM POST PROCEDURE." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6106418 ↗
• MalfunctionNov 9, 2016Material Perforation; Material Perforation

  HYSTERECTOMY- THE ALEXIS CES BAG EXPERIENCED PUNCTURES THEY WERE LOCATED NEAR THE INCISION SITE. THE GUARD WAS USED. THE DOCTOR TO MOVE THE GUARD WITH AN ALICE CLAMP DURING THE PROCEDURE. THE PUNCTURES THAT WERE NOTICED ABOUT 1-2MM, THIS RESULTED IN LIQUID LEAKING INTO THE BAG. TISSUE: PATHOLOGY - SARCOMA. ADDITIONAL INFORMATION RECEIVED VIA PHONE FROM APPLIED MEDICAL TEAM MEMBER AFTER DISCUSSION WITH CUSTOMER ON OCTOBER 17, 2016 - THE SURGEON INSERTED THE ALEXIS CES THROUGH THE GELPOINT MINI SITE. THE INCISION WAS ABOUT 3CM - PATIENT WAS NOT OBESE, BUT WAS HEAVY. ONCE THE SPECIMEN WAS PLACED AND THE RING OF THE BAG WAS PULLED OUT THROUGH THE INCISION THE SURGEON AND FIRST ASSIST STRUGGLED TO PUT THE GUARD IN PLACE. THEY USED ALLIS CLAMPS TO INSERT THE GUARD - THINK THIS MAY HAVE CAUSED THE DAMAGE BUT NO ONE ACTUALLY SAW THEM CREATE A HOLE IN THE BAG. THE DAMAGE TO THE BAG WASN'T NOTICED UNTIL THE END OF THE CASE. THERE WERE 2-3 HOLES FOUND AT THE TOP OF THE BAG. THERE WAS NO DAMAGE TO THE GUARD, JUST THE BAG. IT LOOKED LIKE THE DAMAGE WAS EVEN WITH THE GUARD. ON THIRD CUT WITH THE BLADE, THE SURGEON REALIZED THE UTERUS WAS LIKELY CANCEROUS (CONSISTENCY TURNED TO "CHICKEN FAT"). ON

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6091543 ↗
• MalfunctionSep 20, 2016Material Perforation; Material Perforation

  ROBOTIC TOTAL HYSTERECTOMY -"WHILE EXTRACTING SPECIMEN (LARGE, 700G) VAGINALLY, DOCTOR WAS USING HANDS AND LOTS OF FORCE TO PULL SPECIMEN OUT, AND THE CES BAG BROKE ON BOTTOM OF BAG TOWARDS THE END AND DESCRIBED THE TEAR AS THE SIZE OF A GOLF BALL. REP DESCRIBED THAT THE SURGEON DID NOT MANUALLY MORCELLATE ENOUGH, AND ALSO DID NOT USE THE GUARD." PATIENT STATUS: FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5965387 ↗
• MalfunctionAug 23, 2016Material Perforation; Material Perforation

  ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY - "DR. (B)(6) WAS DISSATISFIED BECAUSE THE BAG RIPPED WHEN TRYING TO EXTRACOPREALIZE THE SPECIMEN. SAID THE BAG MATERIAL COULD USE IMPROVEMENTS. DOCTOR DID MANUALLY MORCELLATE BEFORE REMOVAL. BAG WAS NOT ATTEMPTED TO BE REMOVED BEFORE ALL TISSUE WAS REMOVED. THE TYPE OF TISSUE WAS THE UTERUS. DR. (B)(6) SAW THERE WAS A TEAR NEAR THE ALEXIS RING, GUARD WAS NOT USED. THE RIP WAS NOTICED AT TWO POINTS DURING THE PROCEDURE WAS WHEN HE WAS TRYING TO PLACE THE SPECIMEN IN THE BAG (SAID THE INSTRUMENTATION OF PLACING SPECIMEN THROUGH ALEXIS RING CAUSED A SMALL TEAR). AFTER SPECIMEN WAS PLACED IN THE BAG HE WAS PULLING ON THE ALEXIS RING TO BRING THE SPECIMEN CLOSER TO SURFACE AND HE HAD A SECOND TEAR TAKE PLACE. NOT SURE OF WHAT INSTRUMENTS WERE USED TO PLACE THE BAG IN THE PATIENT OR TO PLACE THE SPECIMEN IN THE BAG." PATIENT STATUS - "NO PATIENT INJURY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5897122 ↗
• MalfunctionJul 12, 2016Break; Torn Material; Break; Torn Material

  MYOMECTOMY- "DURING USE OF THE DEVICE THE SURGEON MADE A SMALL INCISION WITH THE SURGICAL SCISSORS IN THE ALEXIS CES BAG DURING SPECIMEN MORCELATION. " TYPE OF INTERVENTION: "UNKNOWN." PATIENT STATUS: "UNKNOWN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5788311 ↗
• MalfunctionJun 24, 2016Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  LAP SUBTOTAL HYSTERECTOMY; "AFTER RING OF BAG WAS PULLED OUTSIDE OF ABDOMEN WITH SPECIMEN INSIDE, THE GUARD WAS INSERTED. THE SCRUB NURSE HAD CILED THE GUARD UP AT THE BEGINNING OF THE CASE AND CLAMPED IT WITH A HEMOSTAT BEFORE HANDING IT OFF TO THE SURGEON. ONCE THE SURGEON INSERTED THE GUARD, IT DID NOT AUTOMATICALLY EXPAND. THE SURGEON COMMENTED THAT THIS WAS A NUISANCE, AND HAD A HARD TIME MANUALLY EXPANDING THE GUARD. THE INCISION WAS NO MORE THAN 2CM. AS A SEPARATE NOTE, AFTER THE CASE, THE SCRUB NURSE FILLED THE BAG WITH WATER AND NOTICED A HOLE NEAR THE TOP OF THE BAG A FEW CM DOWN FROM THE RING. THE SURGEON SAID HE THOUGHT HE MAY HAVE NICKED THE BAG WHEN IT WAS BUNCHED OUTSIDE THE ABDOMEN DURING MORCELLATION."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5748755 ↗
• MalfunctionJun 15, 2016Break; Hole In Material; Break; Hole In Material

  LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY - "DURING MANUAL MORCELLATION OF SPECIMEN, GAS WAS OBSERVED TO BE LEAKING THROUGH BAG. CONTAINED EXTRACTION SYSTEM WAS INSPECTED AFTER MORCELLATION WAS COMPLETED AND TWO HOLES WERE OBSERVED." PATIENT STATUS - STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5726402 ↗
• MalfunctionJun 8, 2016Hole In Material; Hole In Material

  LAPAROSCOPIC MYOMECTOMY - "SURGEON OBSERVED INSUFFLATION GAS BUBBLING UP AROUND THE SPECIMEN (WITHIN THE BAG) ROUGHLY HALFWAY THROUGH MANUAL MORCELLATION OF 6CM FIBROID. CONTAINED EXTRACTION SYSTEM WAS FILLED WITH SALINE AFTER THE PROCEDURE WAS COMPLETED AND A HOLE WAS IDENTIFIED IN THE BAG. SURGEON DID NO OBSERVE SPILLAGE OF SPECIMEN TISSUE INTO ABDOMINAL CAVITY." PATIENT STATUS - STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5707585 ↗
• MalfunctionJun 7, 2016Cut In Material; Cut In Material

  ROBOT HYSTERECTOMY BSO - "AFTER PLACING THE BAG THROUGH THE 1.5MM INCISION AND PLACING THE UTERUS IN THE BAG, DR. (B)(6) PULLED THE BAG UP TO SKIN LEVEL TO ROLL IT DOWN AND MORCELLATE THE UTERUS. WHEN SHE PUT THE BLADE GUARD IN (THE NEW ONE THAT LOCKS INTO PLACE), SHE WAS STILL HAVING TROUBLE WITH THE BLADE GUARD SLIPPING OUT OF THE INCISION. THE PATIENT'S DR. (B)(6) SPECIALIZES IN ARE OBESE PATIENTS (300-400 LBS) WITH FIBROID-FILLED UTERI. THIS PATIENT WAS OVER (B)(6) AND HAD MANY FIBROIDS ON HER UTERUS. WHEN DR. (B)(6) BROUGHT THE UTERUS TO THE INCISION SURFACE TO MORCELLATE, THE BLADE GUARD WAS NOT ABLE TO ACCOMMODATE THE PATIENT'S THICK ABDOMINAL WALL, EVEN WHEN THE PLACED AN ALEXIS RETRACTOR IN THE INCISION TO COMPRESS THE ABDOMINAL WALL. WHILE TRYING TO BREAK UP THE FIBROIDS, SHE ENDED UP CUTTING THROUGH THE BAG A FEW TIMES WHERE THE BLADE GUARD PROTECTED." PATIENT STATUS: "STABLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5704860 ↗
• InjuryMar 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LAPAROSCOPIC HYSTERECTOMY - "ALEXIS WOUND PROTECTOR WAS PLACED INSIDE OF THE ALEXIS CONTAINED EXTRACTION SYSTEM BAG. IT IS REPORTED THAT THERE WAS BOWEL INJURY." PATIENT STATUS - "PATIENT HAD NO FURTHER COMPLICATIONS AND WAS DISCHARGED 2 DAY STAY." INTERVENTION - "BOWEL ANASTAMOSIS."

  Patient problems: Injury

  MAUDE report 5488156 ↗