Inzii Retrieval System CD003Recalls & reported problems

Summary

The FDA's MAUDE database contains 284 adverse event reports that list this exact device (DI 00607915123406), received between Mar 4, 2016 and Sep 15, 2026 — classified as 2 injuries, 281 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (73 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 25 most recent of 284 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780946 ↗
• MalfunctionAug 25, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434501 ↗
• MalfunctionAug 11, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212973 ↗
• MalfunctionAug 7, 2026Detachment of Device or Device Component

  Procedure performed: Lap Adnexectomy Event Description: On 25 June, there was a problem with an Inzii bag from Applied. Ref CD003, batch 1573509. Problem: a black thread would not come loose after the plunger broke off. This is said to have happened on several occasions. They couldn't take the cord from the hook to release the inzii bag back in the abdomen. First they took adnex out of bag and then they pulled out the bag with deployment system and trocar through the incision. Afterwards they took a new CD003.Type of Intervention: They took a new CD003.Patient Status: Patient ok.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181587 ↗
• InjuryAug 7, 2026Material Split, Cut or Torn

  Procedure Performed: Bilateral Oophorectomy.Event Description: Inzii Universal Bag was deployed into the abdomen to collect the specimen (right ovary). They placed the right ovary into the bag and closed it shut. When they went to pull the bag out with the specimen in it the ovary was no longer in the bag. They are saying that they believe the bag popped or had a hole in it and the right ovary slipped out. They removed the bag with the ovary and then began searching around and through the bowls to find the detached right ovary. They searched for a while and could not find it. They decided it was best to close instead of performing a laparotomy to remove the right ovary. Patient was getting this procedure because it was a risk reduction as she has had cancer twice in the past. GYN Onc is now saying they are doing surgery again to go look and remove the right ovary. Patient is undergoing an additional surgery to find and remove the specimen. Her GYN Onc said it is not safe as a cancer risk patient to have her ovary floating around in the abdomen. She said she is undergoing an additional surgery because the bag did not perform how it is supposed to. The issue has yet to be resolved. P

  Patient problems: Insufficient Information

  MAUDE report 50178709 ↗
• MalfunctionJul 28, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50061219 ↗
• MalfunctionJul 28, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059901 ↗
• MalfunctionJun 26, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: MODEL WAS CD003. TIMING WAS DURING TREATMENT. EVENT DATE WAS 03JUN2026. WAS MADE AWARE AT THE TIME OF THE EVENT. BAG BROKE, TORE AT THE SEAM. NO PATIENT INJURY. NO OTHER DEVICES USED. REMOVED SPECIMEN MANUALLY WITH THEIR HANDS AND A CLAMP. NO, PRODUCT WAS THROWN AWAY BEFORE IT COULD BE RETRIEVED. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 05JUN2026 VIA EMAIL: PACKAGING WAS DISCARDED BEFORE IT COULD BE RETRIEVED FOR DOCUMENTATION. YES, SPECIMEN WAS COMPLETELY EXPOSED ONCE THE BAG BROKE. YES, THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. YES, THEY DID NOT EXTEND THE INCISION. THEY USED CLAMPS TO STRETCH THE FASCIA AND USED CIRCULAR MOTIONS WHEN TRYING TO PULL THE BAG OUT OF THE ABDOMEN. INTERVENTION: REMOVED SPECIMEN MANUALLY WITH THEIR HANDS AND A CLAMP PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25644188 ↗
• MalfunctionJun 25, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: THE BAG WAS BEING USED TO TAKE OUT THE GALL BLADDER. AFTER THE BAG WAS DEPLOYED, RETRACTED, AND BEING PULLED OUT THROUGH THE INCISION IT BROKE FROM THE BOTTOM INTO 3 PIECES. 2 OF THOSE PIECES NEEDED TO BE RETRIEVED FROM THE BODY CAVITY. BEFORE THE SPECIMEN WAS PLACED INTO THE BAG THE SURGEON USED HIS ROBOTIC BI-POLAR DEVICE TO HELP UNROLL THE BAG TO MAKE SPACE FOR THE GALL BLADDER. DEVICE WAS REPLACED WITH A DIFFERENT COMPETITIVE BAG AND THE SPECIMEN REMOVED, THEN THE PIECES OF THE INZII BAG WERE FOUND AND REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 29MAY2026 VIA EMAIL: PATIENT STATUS IS UNKNOWN BUT NO CONCERNS OR INJURIES WERE MENTIONED BY THE DR. AFTER THE CASE DURING OUR MEETING. YES, BILE AND TISSUE SPILLED OUT OF THE BAG WHEN IT BROKE. INTERVENTION: DEVICE WAS REPLACED WITH A DIFFERENT COMPETITIVE BAG AND THE SPECIMEN REMOVED, THEN THE PIECES OF THE INZII BAG WERE FOUND AND REMOVED FROM THE PATIENT. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25629929 ↗
• MalfunctionJun 19, 2026Material Split, Cut or Torn

  EVENT DATE UNKNOWN. PROCEDURE PERFORMED: LAPAROSCOPIC BILATERAL SALPHING-OOPHERECTOMY. EVENT DESCRIPTION: MHRA USER REPORT: SURGEON USED THE ITEM TO ASSIST IN SPECIMEN RETRIEVAL IN A LAPAROSCOPIC CASE. UPON ATTEMPT TO PULL THE RETRIEVAL SYSTEM BAG, THE SURGEON HAD DIFFICULTY SO THEY USED OTHER INSTRUMENTS TO HELP REMOVE THE BAG AND THE SPECIMEN. ONCE THE BAG WAS OUT, IT WAS INSPECTED AND NOTED A RIP PART AND A HOLE ON IT AND HAVE NOTICED A SMALL PAR OF THE BAG WAS MISSING. SURGEON INSPECTED THE BAG THREE TIMES AND LOOKED FOR THE MISSING PIECE INSIDE THE ABDOMINAL CAVITY, PORTS, SPECIMEN AND SUCTION. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2026: NO PATIENT INJURY. IT WAS RESOLVED BY TAKING THE RETRIEVAL BAG WAS OUT, SEARCH FOR THE MISSING PIECE AND DONE LOADS OF PERITONEAL WASH. NO SPILLAGE OUT OF THE DAMAGE TO THE BAG. YES, THE BAG DID BREAK IN TINY PIECE. NOT SURE IF THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE BAG BURST DURING SPECIMEN REMOVAL. THE PORT SIZE WAS NOT ENLARGED, BEEN RETRIEVE ON THE 5MM PORT WITH 5MM RETRIEVAL BAG SPECIMEN FITS WITHIN IN THE BAG. TYPE OF INTERVENTION: RETRIEVAL BAG WAS TAKEN OUT, SEARCH FOR THE M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565458 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC XI LAPAROSCOPIC OVARIAN CYSTECTOMY. EVENT DESCRIPTION: DURING ROBOTIC XI ASSISTED LAPAROSCOPIC OVARIAN CYSTECTOMY TWO SEPARATE 5MM SPECIMEN BAGS BROKE DURING SPECIMEN RETRIEVAL. IT WAS DISCOVERED THAT DOWNWARD PRESSURE OF THE DEPLOYED BAG WILL PUT PRESSURE ON THE WHITE PLASTIC HOUSING CONNECTOR THAT HOLD THE METAL STAYS TO THE RETRACTION DEVICE AND THIS PIECE WILL DISLODGE FROM THE SHAFT CAUSING IT TO POP OFF WHEN THE HANDLE IS RETRACTED TO CINCH THE BAG CLOSED. INSTEAD OF THE METAL STAYS RETRACTING INTO THE DEVICE SHAFT, THE WHITE PIECE POPS OFF, AND THE STAYS FALL OFF WITH IT. PIECES THAT FELL INTO THE PERITONEAL CAVITY WERE RETRIEVED AND ABDOMEN VISUALLY INSPECTED FOR FRAGMENTS WITH ENDOSCOPE. PIECES WERE COMPARED TO INTACT SPECIMEN RETRIEVAL BAG, AND AN INTRAOPERATIVE X-RAY WAS TAKEN TO CONFIRM NO RETAINED FOREIGN MATERIAL. INTERVENTION: USED A THIRD BAG SUCCESSFULLY PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178799 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC XI LAPAROSCOPIC OVARIAN CYSTECTOMY. EVENT DESCRIPTION: DURING ROBOTIC XI ASSISTED LAPAROSCOPIC OVARIAN CYSTECTOMY TWO SEPARATE 5MM SPECIMEN BAGS BROKE DURING SPECIMEN RETRIEVAL. IT WAS DISCOVERED THAT DOWNWARD PRESSURE OF THE DEPLOYED BAG WILL PUT PRESSURE ON THE WHITE PLASTIC HOUSING CONNECTOR THAT HOLD THE METAL STAYS TO THE RETRACTION DEVICE AND THIS PIECE WILL DISLODGE FROM THE SHAFT CAUSING IT TO POP OFF WHEN THE HANDLE IS RETRACTED TO CINCH THE BAG CLOSED. INSTEAD OF THE METAL STAYS RETRACTING INTO THE DEVICE SHAFT, THE WHITE PIECE POPS OFF, AND THE STAYS FALL OFF WITH IT. PIECES THAT FELL INTO THE PERITONEAL CAVITY WERE RETRIEVED AND ABDOMEN VISUALLY INSPECTED FOR FRAGMENTS WITH ENDOSCOPE. PIECES WERE COMPARED TO INTACT SPECIMEN RETRIEVAL BAG, AND AN INTRAOPERATIVE X-RAY WAS TAKEN TO CONFIRM NO RETAINED FOREIGN MATERIAL. INTERVENTION: USED A THIRD BAG SUCCESSFULLY PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178752 ↗
• MalfunctionMay 1, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: IT WAS DURING THE INTRODUCTION INTO THE TROCAR. WHEN REMOVING THE BAG FROM THE DEVICE, IT WAS NECESSARY TO APPLY FORCE TO INSERT IT INTO THE PATIENT¿S ABDOMEN; UPON REMOVAL, THE DEVICE BROKE AND A PIECE OF IT WAS LOST. THE MEDICAL DEVICE WAS REPLACED. TYPE OF INTERVENTION: THEY TOOK A NEW DEVICE PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062258 ↗
• MalfunctionMar 12, 2026

  THERE WAS AN EQUIPMENT MALFUNCTION WHEN THE UNIVERSAL RETRIEVAL SYSTEM 5 MM BAG WOULD NOT DEPLOY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578836 ↗
• MalfunctionMar 12, 2026

  THERE WAS AN EQUIPMENT MALFUNCTION, AND THE 5 MM BAG WOULD NOT DEPLOY.

  Patient problems: Insufficient Information

  MAUDE report 24578807 ↗
• MalfunctionMar 5, 2026Difficult to Open or Close

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: AI TRANSLATED: I WISH TO INFORM YOU OF A QUALITY DEFECT THAT OCCURRED ON (B)(6) 2026, CONCERNING THE FOLLOWING DEVICE: PRODUCT: RETRIEVAL BAG. REF: CD003. BATCH: 1558541. EXPIRY DATE: JUNE 22, 2028. DESCRIPTION OF THE INCIDENT: DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG DEPLOYED AND CLOSED CORRECTLY, BUT ONCE THE SUTURE WAS REMOVED FROM THE ABDOMEN, THE BAG IMMEDIATELY CAME LOOSE INSIDE THE PATIENT. THIS PROBLEM HAS ALREADY OCCURRED TWICE. THIS RESULTS IN A LOSS OF TIME AND A RISK OF LOSING THE SURGICAL SPECIMEN. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515666 ↗
• MalfunctionFeb 12, 2026Material Split, Cut or Torn

  EVENT DESCRIPTION: 5MM ENDOCATCH BAG RUPTURED IN SURGERY DURING SPECIMEN REMOVAL. OCCURRED ONE OTHER TIME ON A DIFFERENT DATE PER SURGEON. OPENED A [COMPETITOR] RIPSTOP BAG TO COMPLETE PROCEDURE. ADDITIONAL INFORMATION PROVIDED BY [NAME] VIA PHONE CALL WITH [NAME]: [NAME] CALLED AND WANTED TO LET YOU KNOW THE FOLLOWING INFORMATION REGARDING THE COMPLAINT HE JUST REPORTED A FEW MINUTES AGO: FIRST INCIDENT HAPPENED (B)(6) 2026. THE PRONGS WERE NOT EXPOSED IN EITHER INSTANCE; IT WAS JUST THE BAG. CD003 (SAME MODEL FOR BOTH EVENTS). INTERVENTION: OPENED A [COMPETITOR] RIPSTOP BAG. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329138 ↗
• MalfunctionJan 8, 2026Premature Separation

  PROCEDURE PERFORMED: PROSTATECTOMY. EVENT DESCRIPTION: 3 CD003 BROKE 1ST BAG- WOULD NOT CLOSE, STRING CAME OUT OF BAG, BAG WAS DROPPED INTO PATIENT. 2ND BAG- WOULD NOT DEPLOY 3RD BAG- WOULD NOT CLOSE, STRING CAME OUT OF BAG WAS DROPPED INTO THE PATIENT. HAD TO EXTEND INCISION, BECAUSE THE BAG, STRING AND SPECIMEN WERE LOST IN THE PATIENT. HOSPITAL REQUESTED ALL OF THOSE BAGS BE PULLED FROM THE SHELF, AND FOR UPCOMING PROCEDURES. THIS INCLUDES AT LEAST 9 BAGS, THERE ARE MORE BOXES DOWNSTAIRS AS WELL, THAT SUPPLY DEPT HAS REQUESTED NOT BE USED. 18 TOTAL BAGS NEED TO BE REPLACED. ROBOT INST, ROBOT TROCARS, AIR SEAL APPLIED MEDICAL GRASPER. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 10DEC2025 PER EMAIL: AFTER RECEIVING THE EMAIL WITH THE QUESTIONS ABOUT THE GUIDE BEAD, I RETURNED TO THE HOSPITAL TO SPEAK WITH THE OR STAFF AND CHECK THE BAGS FROM THE CASE. I HAD INSTRUCTED THE STAFF TO SAVE THE DEFECTIVE BAGS TO RETURN TO APPLIED. UPON CHECKING THE BIOHAZARD BAG WHERE THE ITEMS WERE PLACED, I FOUND ONLY THE INTRODUCERS; THE SPECIMEN BAGS THEMSELVES, WHERE THE GUIDE BEADS SHOULD HAVE BEEN ATTACHED WERE NOT PRESENT. TWO OF THE INTRODUCERS STILL HAD THE STRINGS ATTACHED; HOWEVER, THE STR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012969 ↗
• MalfunctionJan 8, 2026Premature Separation

  PROCEDURE PERFORMED: PROSTATECTOMY. EVENT DESCRIPTION: 3 CD003 BROKE 1ST BAG- WOULD NOT CLOSE, STRING CAME OUT OF BAG, BAG WAS DROPPED INTO PATIENT. 2ND BAG- WOULD NOT DEPLOY 3RD BAG- WOULD NOT CLOSE, STRING CAME OUT OF BAG WAS DROPPED INTO THE PATIENT. HAD TO EXTEND INCISION, BECAUSE THE BAG, STRING AND SPECIMEN WERE LOST IN THE PATIENT. HOSPITAL REQUESTED ALL OF THOSE BAGS BE PULLED FROM THE SHELF, AND FOR UPCOMING PROCEDURES. THIS INCLUDES AT LEAST 9 BAGS, THERE ARE MORE BOXES DOWNSTAIRS AS WELL, THAT SUPPLY DEPT HAS REQUESTED NOT BE USED. 18 TOTAL BAGS NEED TO BE REPLACED. ROBOT INST, ROBOT TROCARS, AIR SEAL APPLIED MEDICAL GRASPER. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 10DEC2025 PER EMAIL: AFTER RECEIVING THE EMAIL WITH THE QUESTIONS ABOUT THE GUIDE BEAD, I RETURNED TO THE HOSPITAL TO SPEAK WITH THE OR STAFF AND CHECK THE BAGS FROM THE CASE. I HAD INSTRUCTED THE STAFF TO SAVE THE DEFECTIVE BAGS TO RETURN TO APPLIED. UPON CHECKING THE BIOHAZARD BAG WHERE THE ITEMS WERE PLACED, I FOUND ONLY THE INTRODUCERS; THE SPECIMEN BAGS THEMSELVES, WHERE THE GUIDE BEADS SHOULD HAVE BEEN ATTACHED WERE NOT PRESENT. TWO OF THE INTRODUCERS STILL HAD THE STRINGS ATTACHED; HOWEVER, THE STR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011834 ↗
• MalfunctionDec 9, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  DATE OF EVENT: UNKNOWN. NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT: I AM REACHING OUT ON BEHALF OF MY CUSTOMER, [FACILITY] TO REPORT A CER. I WAS CONTACTED THIS MORNING BY [NAME], IN THE PURCHASING DEPT OF [FACILITY]. SHE STATED, "PLEASE SEE ATTACHED PICTURE AS THIS ITEM DELIVERED WITH AN EYELASH IN THE STERILE PACKAGING. TYPE OF INTERVENTION: NA (BEFORE USE). PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763129 ↗
• MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSCOPIC SALPINGECTOMY. EVENT DESCRIPTION: THE CD003 WAS USED WITHOUT AN APPLIED MEDICAL 5MM TROCAR. THE GYN FELLOW, DR. [NAME], DEPLOYED THE BAG THROUGH THE INCISION. TOO SMALL OF AN INCISION AND WHEN THE SPECIMEN WAS IN THE BAG AND THE SURGEON TRIED PULLING THE BAG OUT, THE BAG BROKE. NO PATIENT INJURY. THE CASE WAS LAST FRIDAY, 10/17. I WASN'T AT THE CASE AND I WAS INFORMED AND MET WITH THE GYN COORDINATOR AND FELLOW. BAG WASN'T KEPT. SURGEON AND GYN COORDINATOR SAID THAT IT WAS A PIECE THAT IS LESS 1MM THAT BROKE OFF OF THE BAG. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 24OCT2025: NO SPILLAGE REPORTED TO ME THE SURGEON SAID THAT A SMALL PIECE LESS THAN 1MM BROKE OFF AND LEFT IN THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 11NOV2025: JUST FOLLOWED UP WITH THE ACCOUNT AGAIN THIS MORNING AND THE LOT # IS UNKNOWN. INTERVENTION: A SMALL PIECE LESS THAN 1MM BROKE OFF AND LEFT IN THE PATIENT. PATIENT STATUS: TOLD BY THE SURGEON THAT THE PATIENT ISN'T INJURED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622566 ↗
• MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: RE-EXPLORATION SURGERY. EVENT DESCRIPTION: THE COMPLAINT WAS GENERATED FROM MEDSUN UF/IMPORTER REPORT (B)(4) RECEIVED ON 23SEP2025 SURGERY PERFORMED [DATE REDACTED] - REMOVAL OF GASTRIC FOREIGN BODY. RE-EXPLORATION SURGERY PERFORMED [DATE REDACTED] - 6 DAYS AFTER SURGERY - DISCOVERY OF 5 MM ENDOCATCH BAG IN THE ABDOMEN MISSING BLACK STRING. INTERVENTION: REMOVAL OF GASTRIC FOREIGN BODY, RE-EXPLORATION SURGERY PERFORMED. PATIENT STATUS: NO PATIENT INJURY. REMOVAL OF GASTRIC FOREIGN BODY, RE-EXPLORATION SURGERY PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23373428 ↗
• MalfunctionSep 11, 2025Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: TWO BAGS WERE USED IN THE SAME PROCEDURE. BOTH BAGS HAD FRACTURES IN THE BAG AND THE BAGS BROKE. THERE WAS SPILLAGE OUT OF THE BAGS. BOTH BAGS WERE THE SAME LOT NUMBER. INTERVENTION: UNK. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027918 ↗
• MalfunctionSep 11, 2025Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: TWO BAGS WERE USED IN THE SAME PROCEDURE. BOTH BAGS HAD FRACTURES IN THE BAG AND THE BAGS BROKE. THERE WAS SPILLAGE OUT OF THE BAGS. BOTH BAGS WERE THE SAME LOT NUMBER. INTERVENTION: UNK. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027689 ↗
• InjuryAug 28, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PROCEDURE PERFORMED: NIEVENT DESCRIPTION: ON (b)(6) 25, I RECEIVED INFORMATION THAT THREE INSTANCES HAVE OCCURRED OF OUR CD003 BAG BREAKING AT THE HOSPITAL. I WENT THERE TODAY, AND THE FOLLOWING INFORMATION WAS PROVIDED. ALTHOUGH THE INFORMATION IS NOT COMPLETE, I WANTED TO COMMUNICATE IT RIGHT AWAY. I WILL BE THERE AGAIN TOMORROW TO CONTINUE FINDING OUT INFORMATION.DATE: SOMETIME IN JUNEPRODUCT: CD003 OR CD001- THE HOSPITAL WAS UNSURE BUT WILL LOOK TO SEE IF THEY HAVE THE REPORT.SURGEON: POSSIBLY DR. NAMEINCIDENT: STRING BROKE OFF DURING REMOVAL WITH THE SPECIMEN. THE BAG WAS ACCIDENTALLY LEFT IN THE PATIENT. THE BAG WAS REMOVED AT A LATER DATE. ADDITIONAL INFORMATION RECEIVED ON (b)(6) 2025 BY ACCOUNT MANAGER VIA EMAIL:AS OF RIGHT NOW, THERE IS NOT ADDITIONAL INFORMATION FOR ME TO SHARE. I AM CONTINUING TO PURSUE ANSWERS FOR THE QUESTIONS BELOW. I WILL KEEP YOU POSTED.ADDITIONAL INFORMATION PROVIDED BY MEDSUN UF/ IMPORTER REPORT # 2300530000-2025-8023 RECEIVED ON(b)(6) 2025:DESCRIBE THE EVENT OR PROBLEM: SURGERY PERFORMED "[DATE REDACTED]" - REMOVAL OF GASTRIC FOREIGN BODY RE-EXPLORATION SURGERY PERFORMED DATE REDACTED - 6 DAYS AFTER SURGERY - DISCOVERY OF 5 MM ENDOCATCH BAG IN T

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919478 ↗