Inzii Retrieval System CD001Recalls & reported problems

Summary

The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 00607915117382), received between Feb 8, 2016 and Sep 24, 2026 — classified as 355 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (100 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 355 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892481 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858556 ↗
• MalfunctionAug 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507297 ↗
• MalfunctionAug 7, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176821 ↗
• MalfunctionAug 7, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168696 ↗
• MalfunctionMay 14, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: DAVINCI ASSIST RADICAL PROSTATECTOMY. EVENT DESCRIPTION: THE COMPLAINT WAS GENERATED FROM MEDSUN UF/IMPORTER REPORT# (B)(4). DURING A DAVINCI ASSIST RADICAL PROSTATECTOMY THE ENDOCATCH BAG BROKE UPON EXTRACTION OF THE SPECIMEN. DATE OF EVENT: MAR-2026. INTERVENTION: THE UNDERSIDE WAS RETRIEVED AND LAPAROSCOPY SHOWED NO FURTHER PIECES IN THE ABDOMEN; THE ENTIRE SPECIMEN WAS REMOVED WITH NONE LEFT BEHIND PER THE MEDICAL RECORD. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176327 ↗
• MalfunctionMay 6, 2026Premature Separation

  PROCEDURE PERFORMED: LC. EVENT DESCRIPTION: UPON DEPLOYMENT, THE RETRIEVAL BAG DROPPED DIRECTLY INTO THE PATIENT'S BODY. THE SURGEON ATTEMPTED TO RETRIEVE THE SPECIMEN INTO THE BAG USING OTHER INSTRUMENTS; HOWEVER, AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE BAG WAS REPLACED WITH A NEW ONE TO ACHIEVE THE OBJECTIVE. ADDITIONAL INFORMATION PROVIDED BY [DISTRIBUTOR] VIA EMAIL ON (B)(6) 2026: THE TIPS OF THE SUPPORTS WERE EXPOSED INSIDE THE PATIENT. THE SUPPORTS DID NOT REMAIN INSIDE THE INTRODUCER TUBE. THE BAG FELL DOWN THE SUPPORTS IMMEDIATELY UPON THE FULL DEPLOYMENT OF THE ACTUATOR. THE ACTUATOR WAS NOT PUSHED FORWARD, RETRACTED, AND THEN DEPLOYED AGAIN. THE GUIDE BEAD WAS NOT PULLED ON WITH AN INSTRUMENT AND THE GUIDE BEAD DID NOT DETACH FROM THE BAG OR CORD. TYPE OF INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: NO CLINICAL IMPACT. THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095272 ↗
• MalfunctionMar 24, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: MEDWATCH # MW5182957 LAPAROSCOPIC 10MM RETRIEVAL BAG TORE. INTERVENTION: NI PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682806 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: HOW WAS THE DEVICE BEING USED: NO INFORMATION WAS GIVEN- TO BE UPDATED METAL RING BROKE WHEN DEPLOYING. NO CLINICAL IMPACT TO PATIENT. 16.02.2026 - ADDITIONAL INFORMATION RECEIVED FROM [NAME] (TERRITORY MANAGER) VIA EMAIL: DID PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT: NO INJURY OR ILLNESS HOW WAS THE DEVICE BEING USED/WHAT ACTION WAS BEING PERFORMED WHEN THE EVENT OCCURRED: LAP CHOLE PROCEDURE, INSERTING INZI CD001 THROUGH APPLIED MEDICAL 5M TROCARS CFFO3 DESCRIBE THE EVENT, INCLUDING RELEVANT INCLUDING ANY RELEVANT INFORMATION: WHEN SURGEON DEPLOYING THE INZI CD001 THROUGH APPLIED MEDICAL 5M TROCARS THE METAL ARMS DETHATCHED FROM INTRODUCER. HOW DID THE USER RESOLVE THE SITUATION: THEY USED ANOTHER INZII CD001 BAG WITH NO ISSUE WHAT OTHER INSTRUMENTS (IF ANY) WERE USED WHEN THE COMPLAINT EVENT OCCURRED: CFF03 19.02.2026 IN RESPONSE TO [APPLIED MEDICAL TEAM MEMBER] REQUEST FOR ADDITIONAL INFORMATION: COULD YOU PLEASE CONFIRM WHETHER THE CUSTOMER IS REFERRING TO THE SAME COMPONENT WHEN THEY MENTION THE ¿RING¿ AND THE ¿METAL ARMS¿, OR IF THEY ARE DESCRIBING TWO DIFFERENT PARTS OF THE DEVICE: YES, THE CUSTOM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573138 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP CHOLE EVENT DESCRIPTION: PICTURED PLASTIC PIECE (GUIDE BEAD?) FELL OFF FROM THE BAG INSIDE THE PATIENT. THE PIECE WAS RETRIEVED FROM THE PATIENT. THE DEVICE WAS USED IN THE PROCEDURE. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON (B)(6) 2026: PICTURED PLASTIC PIECE (GUIDE BEAD?) FELL OFF THE BAG INSIDE THE PATIENT. BAG WAS UTILIZED TO TAKE SPECIMEN OUT AND WHEN SURGEON WAS DOING HER FINAL CHECK, LOOK AROUND INSIDE ABDOMEN THEN SAW THIS PLASTIC PIECE. PLASTIC PIECE RETRIEVED FROM PATIENT¿S BODY WITHOUT ANY INJURY. NO OTHER PRODUCT WAS USED TO REPLACE THE BAG DURING THE PROCEDURE. THERE WAS NO SPILLAGE OUT OF THE BAG OPENING. THE GUIDE BEAD WAS NOT PULLED ON WITH AN INSTRUMENT. THE GUIDE BEAD DID NOT DETACH FROM THE BAG. THE GUIDE BEAD DID NOT DETACH FROM THE CORD. YEAH TURNS OUT, THE EVENT WAS ON (B)(6) 2026. IT WAS FIRST REPORTED TO ME ON 1/12/26. INTERVENTION: CASE COMPLETED PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319686 ↗
• MalfunctionFeb 5, 2026Premature Separation

  PROCEDURE PERFORMED: PROCEDURE PERFORMED: ROBOTIC THORACIC CASE. EVENT DESCRIPTION: RETRIEVAL BAG WAS BEING DEPLOYED IN THE CHEST DURING ROBOTIC CASE. NO BAG INSIDE THE RETRIEVAL SYSTEM. NO CLINICAL IMPACT TO PATIENT. ON 02.02.2026 - ADDITIONAL INFORMATION RECEIVED FROM [NAME] (TERRITORY MANAGER) VIA EMAIL: I WAS DOING A ROBOTIC THORACIC CASE. THE BED SIDE ASSISTANT INTRODUCED THE SYSTEM INTO THE CHEST CAVITY. I COULD ONLY SEE THE METAL TIP OF THE FRAME OF THE BAG INTRODUCER. AT THAT POINT, WE WERE UNSURE IF THE BAG HAD DISCONNECTED FROM THE INTRODUCER AND WAS LOST IN THE PLEURAL CAVITY. WE SPENT A SIGNIFICANT AMOUNT OF TIME LOOKING FOR THE BAG, INCLUDING XRAY AS THE BAG CONTAINS A ROUNDED SUTURE SNUGGER WITH METAL RING. NO BAG WAS EVENTUALLY FOUND, PROMPTING US TO THINK THAT THE DEVICE CAME WITH NO BAG AT ALL. THIS WAS DISCLOSED TO THE PATIENT AND FAMILY WHO WERE VERY DISTRESSED IF THE BAG WAS STILL INSIDE THE BAG. FAMILY WAS ALSO COMPLAINING IF THE POST-OPERATIVE PAIN WAS RELATED TO THE PROLONGED TIME OF SURGERY. HAVE YOU EVER HEARD ABOUT A FAULTY SYSTEM OR ANY OTHER SIMILAR COMPLAINT? THIS ALSO CREATED UNNECESSARY DISTRESS FOR ALL THE MEMBERS OF THE TEAM INVOLVED. SO FAR, I HAVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274460 ↗
• MalfunctionJan 15, 2026Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: GALLBLADDER REMOVAL DETAILED DESCRIPTION OF EVENT: THE ARTICLE WAS OPENED STERILE IN THE OPERATING ROOM. WHEN THE STERILE PACKAGE WAS OPENED, A HAIR WAS FOUND IN THE PACKAGE. THIS DID NOT GUARANTEE STERILITY, THE ARTICLE WAS NOT USABLE. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 02JAN26: PHOTOS IN THE ATTACHMENT. IT HAPPENED NOT DURING THE PROCEDURE, BEFORE USE, DURING UNPACKING, (B)(6) 2025. EVENT DATE AND PROCEDURE NAME FIELDS UPDATED. PATIENT STATUS: NA (BEFORE USE). TYPE OF INTERVENTION: A NEW CD001 WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24089750 ↗
• MalfunctionDec 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC ASSISTED RADICAL PROSTATECTOMY. EVENT DESCRIPTION: DURING SPECIMEN RETRIEVAL, THE BAG OF THE CD001 DEVICE RUPTURED. THERE IS NO IMPACT TO PATIENT. TYPE OF INTERVENTION: NI. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882941 ↗
• MalfunctionOct 31, 2025Premature Separation; Premature Separation

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: PRODUCT: CD001 (10MM SPECIMEN BAG CATCHER) LOT: 1560079, EXPIRATION DATE: 6/10/2028, DATE REPORTED TO ME: (B)(6) 2025, DATE OF THIS REPORT: (B)(6) 2025, DOCTOR: [NAME], PATIENT ID: (B)(6), DELAY IN SURGERY: YES; APPROXIMATELY 2 MINUTES, PATIENT INJURY? NO, REPORTED BY: [NAME], CST IN SURGERY, PRODUCT LOCATION: I CURRENTLY HAVE USED/DEFECTIVE PRODUCT IN MY DUR AREA IN SPD. PER [NAME], ¿SURGEON DEPLOYED THE ENDOCATCH BAG AND SILVER METAL PIECES OF DEVICE DEPLOYED; HOWEVER, THE BAG PORTION WAS NOT ATTACHED AND THEREFORE DID NOT OPEN¿ RESULT: ROOM OPENED ANOTHER UNIT AND PROCEEDED SUCCESSFULLY. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 03OCT2025 VIA EMAIL: THE PRODUCT IS AVAILABLE FOR RETURN. THE PATIENT WASN¿T INJURED. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 08OCT2025 VIA EMAIL: YES, THE BAG COMPLETELY FELL OFF THE METAL SUPPORTS. YES, THE TIPS EXPOSED INSIDE THE PATIENT. THE BAG FELL OFF IMMEDIATELY UPON FULL DEPLOYMENT. THE ACTUATOR WAS PUSHED FORWARD, RETRACTED AND THEN FULL DEPLOYED JUST WHEN DEPLOYED - WHEN DEPLOYED THE METAL PIECES DEPLOYED, BUT THE BAG STAYED FOLDED UP. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 09OCT2025 VIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442405 ↗
• MalfunctionSep 19, 2025Break; Break

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: EVENT DATE IS UNKNOWN. THE BAG TORE DURING REMOVAL FROM THE BODY. THE CUSTOMER DID NOT SPECIFICALLY REPORT THIS AS A COMPLAINT. DURING AN OPERATING ROOM VISIT, IT WAS MENTIONED THAT OUR RETRIEVAL BAGS SOMETIMES TEAR WHEN REMOVED FROM THE BODY. WE HAVE TAKEN NOTE OF THIS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 04SEP25: THE NOTICE ABOUT THE BAG TEARING WAS POSTED MORE AS A GENERAL COMMENT THAN AS A COMPLAINT. BECAUSE WE WERE THERE FOR A DIFFERENT ISSUE, WE DIDN'T PAY TOO MUCH ATTENTION TO IT. I UNDERSTAND THAT YOU NEED MORE INFORMATION. THE PERSON WHO REPORTED IT IS CURRENTLY ON VACATION. I WILL FOLLOW UP WITH HER AFTER HER VACATION. I WILL SEE WHEN I CAN STOP BY AND DISCUSS THIS WITH HER. SO, IT MAY TAKE A WHILE. INTERVENTION: NI. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101148 ↗
• MalfunctionSep 19, 2025Break; Break

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: EVENT DATE IS UNKNOWN. THE BAG TORE DURING REMOVAL FROM THE BODY. THE CUSTOMER DID NOT SPECIFICALLY REPORT THIS AS A COMPLAINT. DURING AN OPERATING ROOM VISIT, IT WAS MENTIONED THAT OUR RETRIEVAL BAGS SOMETIMES TEAR WHEN REMOVED FROM THE BODY. WE HAVE TAKEN NOTE OF THIS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 04SEP25: THE NOTICE ABOUT THE BAG TEARING WAS POSTED MORE AS A GENERAL COMMENT THAN AS A COMPLAINT. BECAUSE WE WERE THERE FOR A DIFFERENT ISSUE, WE DIDN'T PAY TOO MUCH ATTENTION TO IT. I UNDERSTAND THAT YOU NEED MORE INFORMATION. THE PERSON WHO REPORTED IT IS CURRENTLY ON VACATION. I WILL FOLLOW UP WITH HER AFTER HER VACATION. I WILL SEE WHEN I CAN STOP BY AND DISCUSS THIS WITH HER. SO, IT MAY TAKE A WHILE. INTERVENTION: NI PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100699 ↗
• MalfunctionAug 28, 2025Break; Break

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: THERE WAS AN ADDITION BAG THAT BROKE LAST EVENING ON (B)(6) 2025. HOWEVER, I DO NOT HAVE THE INFORMATION FROM THE REPORT AND WAS TOLD IT WILL NOT BE AVAILABLE UNTIL POSSIBLY MONDAY. ADDITIONAL INFORMATION RECEIVED ON 12AUG2025 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 RECEIVED ON 14AUG2025 BY ACCOUNT MANAGER VIA EMAIL: UNKNOWN IF THERE WAS SPILLAGE. THE BAD DID NOT BREAK INTO PIECES. THE BAG DID BURSE DURING SPECIMEN REMOVAL. IT WAS A PROSTATE BEING REMOVED. UNKNOWN IF THE SIZE PORT WAS ENLARGED. 10MM BAG - LOT #1550874 AND LOT#1545920 WERE BOTH USED IN THIS CASE. ONE OF THE BAGS BROKE AND THE SECOND BAG WAS USED WITHOUT ISSUE. UNFORTUNATELY, THEY WERE NOT ABLE TO DISTINGUISH WHICH WAS THE BAG THAT BROKE. IT DID NOT FRAGMENT ACCORDING TO THE HOSPITAL REPORT. NO PHOTOS AVAILABLE. INTERVENTION: THE SECOND BAG WAS USED WITHOUT ISSUE. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917905 ↗
• MalfunctionAug 25, 2025Premature Separation; Premature Separation

  PROCEDURE PERFORMED: PARTIAL NEPHRECTOMY. EVENT DESCRIPTION: THE ISSUE OCCURRED WITH TWO UNITS OF THE INZII RETRIEVAL SYSTEM DURING SURGERY. FOR BOTH UNITS, WHEN THE USER PUSHED THE THUMB RING FORWARD TO ADVANCE THE BAG, THE BAG IMMEDIATELY DETACHED. THE BLACK CORD WAS NOT CONNECTED TO THE ACTUATION ROD AND SEPARATED COMPLETELY, MAKING THE DEVICE UNUSABLE. THE SAME ISSUE OCCURRED WITH THE SECOND UNIT. THE PROCEDURE WAS ONLY COMPLETED SUCCESSFULLY AFTER SWITCHING TO A THIRD UNIT. UNFORTUNATELY, THE HOSPITAL DID NOT RETAIN THE TWO DEFECTIVE UNITS, SO WE ARE UNABLE TO RETURN THEM TO APPLIED FOR EVALUATION. THERE IS NO IMPACT TO PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 31JUL2025: THE TWO UNITS WERE NOT LOST AS INITIALLY REPORTED. THEY ARE NOW BEING SHIPPED BACK TO OUR TAIPEI HEADQUARTERS FROM THE CUSTOMER SITE IN (B)(6). UPON ARRIVAL IN (B)(6), WE WILL ARRANGE RETURN SHIPMENT TO APPLIED MEDICAL FOR YOUR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 04AUG2025: YES, THE BAG COMPLETELY FELL OFF THE SUPPORTS. THE TIPS OF THE SUPPORTS WERE SLIGHTLY EXPOSED INSIDE THE PATIENT. NO, THERE WAS NO SPILLAGE OUT OF THE BAG OPENING. WHEN THE BAG FELL OFF, IT WAS STILL AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890381 ↗
• MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: CHOLECISTECTOMY. EVENT DESCRIPTION: DEVICE USED DURING ENDOSCOPIC SURGERY FOR THE REMOVAL OF ANATOMICAL PARTS. ONCE THE DEVICE WAS INSERTED INTO THE PATIENT, THE GALLBLADDER WAS ENCASED IN A BAG. THE GALLBLADDER WAS SECURED. THE BAG WAS THEN CLOSED USING THE CORRECT METHOD. AT THIS POINT, A BREAKAGE OF THE END CAP OF THE DEVICE WAS NOTICED. THIS FINAL PORTION REMAINED INSIDE THE DEVICE, BUT THERE WAS A RISK THAT IT COULD FALL INTO THE ABDOMINAL WALL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA PCF FORM ON 13AUG25: DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON INTRODUCED THE RETRIEVAL BAG CD001 INTO THE ABDOMEN, BAGGED THE GALLBLADDER, CLOSED THE RETRIEVAL TO PULL IT OUTSIDE ABDOMEN. WHILE CLOSING THE BAG SHE NOTICED THAT THE GREEN GUIDE WAS FALLEN INSIDE THE BAG (LUCKILY DIDN'T FALL IN THE ABDOMEN). THE DEVICE WAS USED AS USUAL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 01SEP25: THEY JUST CHECKED NOTHING HAD REMAINED IN THE ABDOMEN. NO SPILLAGE OUT OF BAG OPENING. THE GUIDE BEAD WAS NOT PULLED ON WITH AN INSTRUMENT. THE GUIDE BAG DETACHED FROM THE BAG. THE BAG WAS DAMAGED. THE GUIDE BEAD DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883811 ↗
• MalfunctionAug 22, 2025Premature Separation; Premature Separation

  PROCEDURE PERFORMED: PARTIAL NEPHRECTOMY. EVENT DESCRIPTION: THE ISSUE OCCURRED WITH TWO UNITS OF THE INZII RETRIEVAL SYSTEM DURING SURGERY. FOR BOTH UNITS, WHEN THE USER PUSHED THE THUMB RING FORWARD TO ADVANCE THE BAG, THE BAG IMMEDIATELY DETACHED. THE BLACK CORD WAS NOT CONNECTED TO THE ACTUATION ROD AND SEPARATED COMPLETELY, MAKING THE DEVICE UNUSABLE. THE SAME ISSUE OCCURRED WITH THE SECOND UNIT. THE PROCEDURE WAS ONLY COMPLETED SUCCESSFULLY AFTER SWITCHING TO A THIRD UNIT. UNFORTUNATELY, THE HOSPITAL DID NOT RETAIN THE TWO DEFECTIVE UNITS, SO WE ARE UNABLE TO RETURN THEM TO APPLIED FOR EVALUATION. THERE IS NO IMPACT TO PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 31JUL2025: THE TWO UNITS WERE NOT LOST AS INITIALLY REPORTED. THEY ARE NOW BEING SHIPPED BACK TO OUR TAIPEI HEADQUARTERS FROM THE CUSTOMER SITE IN SOUTHERN TAIWAN. UPON ARRIVAL IN TAIPEI, WE WILL ARRANGE RETURN SHIPMENT TO APPLIED MEDICAL FOR YOUR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 04AUG2025: YES, THE BAG COMPLETELY FELL OFF THE SUPPORTS. THE TIPS OF THE SUPPORTS WERE SLIGHTLY EXPOSED INSIDE THE PATIENT. NO, THERE WAS NO SPILLAGE OUT OF THE BAG OPENING. WHEN THE BAG FELL OFF, IT WAS STI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22876913 ↗
• MalfunctionJul 3, 2025Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAP CHOLE (GALL BLADDER REMOVAL). EVENT DESCRIPTION: THERE WAS A ONE TIME OCCURRENCE WHERE DR. [NAME} WAS PERFORMING A LAP CHOLE AND WHEN PULLING THE BAG THROUGH THE 11MM PORT (NON-APPLIED MEDICAL TROCAR, POSSIBLY [COMPETITOR]) THE BAG RIPPED LEAVING THE GALLBLADDER IN THE BAG FALLING BACK INTO THE PATIENT'S BODY. THE BAG AND THE GALLBLADDER THAT FELL INSIDE THE PATIENT WERE REMOVED OUT OF THE BODY. THE REST OF THE CASE WAS COMPLETED AS USUAL. IT IS UNKNOWN WHETHER ANOTHER INZII BAG WAS USED TO RETRIEVE THE SPECIMEN. INTERVENTION: EXTRACTED THE SPECIMEN, THE REST OF THE CASE WAS DONE AS USUAL. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22399777 ↗
• MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC BSO. EVENT DESCRIPTION: THE DEVICE WAS DEPLOYED TO REMOVE TUBE AND OVARY'S FROM THE PATIENT. THE DEPLOYMENT OF THE BAG OCCURRED AS NORMAL HOWEVER WITH MORE CAUTION DUE TO PREVIOUS ISSUES OF THE BEAD COMING OFF DURING DEPLOYMENT, THEREFORE SLOWLY THE STICK WAS DEPLOYED WITH THE BAG OPENING AND THE SPECIMEN BEING PLACED INSIDE, THE HANDLE COULD NOT BE PULLED BACK AND THE SCRUB NURSE TOOK OVER TO FULLY DEPLOY THE BAG TO THE END OF THE RATCHET SYSTEM AND THEN PULLED THE HANDLE ALL THE WAY BACK TO EXPOSE THE THREAD, UNLOOP THE CORD AND REMOVE THE STICK FOLLOWED BY THE TROCAR. WHEN REMOVING THE STICK, THE BEAD FELL OUT OF THE STICK AND WAS FULLY SEPARATED FROM THE BAG ITSELF. THE BEAD WAS IN TWO PARTS AND NOT AS ONE BEAD. FROM PREVIOUS INCIDENCES THE BEAD IS NOW INCLUDED ON THE SCRUB TECHS COUNT AND SO THE BEAD IS ACCOUNTED FOR IN ALL CASES WHERE IT IS USED TO AVOID FOREIGN BODY BEING LEFT INSIDE A PATIENT. INTERVENTION: FROM PREVIOUS INCIDENCES THE BEAD IS NOW INCLUDED ON THE SCRUB TECHS COUNT AND SO THE BEAD IS ACCOUNTED FOR IN ALL CASES WHERE IT IS USED TO AVOID FOREIGN BODY BEING LEFT INSIDE A PATIENT. PATIENT STATUS: PATIENT STATUS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341670 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NA. EVENT DESCRIPTION: COMPLAINT 1 OF 3: 2025-000990, COMPLAINT 2 OF 3: 2025-001076, COMPLAINT 3 OF 3: 2025-001077. DURING A CHOLECISTECTOMY DURING THE MOMENT TO CLOSE THE ENDOBAG WITH THE SPECIMEN INSIDE. THE DOCTOR START TO INSERT THE INZII TO PUT INSIDE THE CHOLECYST SO HE STARTED TO PUSH THE PISTON TO GET THE BAG, HE INSERT THE SPECIMEN, WHEN THEY WERE STARTING TO PULL THE PISTON UP AND TAKE OFF THE GUIDE WIRE THE BAG STUCK IN THE TUBE HOLE. THE DOCTOR TRY SEVERAL TIME TO TAKE DOWN THE BAG AND SO USING STRENGTH THE BAG GET DOWN BUT THE PROBLEM IS THE ROUND GREEN GUIDE WIRE ON THE TOP THAT IS NOT MORE FIXED IN THE WIRE. THE PATIENT IS OK, BUT THE PROBLEM IS THE ROUND GREEN LITTLE BALL THAT ON THE WIRE GUIDE. THIS CAN FALL INTO THE ABDOMEN. THEY FORCED THE BAG FROM THE METAL TUBE AND IN SOME WAYS ( A LOT) THEY FINALLY CLOSED THE BAG AND TAKE IT AWAY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16APR25: I HAVE TWO STERILE SAMPLE OPENED FOR ME FROM THE 2 DIFFERENT BOXES TO VERIFY THE PROBLEM, THE THIRD SAMPLE ( THAT THEY USED IN THE OR) THEY GIVE ME ONLY THE PAPER REF BECAUSE THE SAMPLE WAS THREW IT AWAY AND THEY SHOW ME THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032279 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NA. EVENT DESCRIPTION: DURING A CHOLECISTECTOMY DURING THE MOMENT TO CLOSE THE ENDOBAG WITH THE SPECIMEN INSIDE. THE DOCTOR START TO INSERT THE INZII TO PUT INSIDE THE CHOLECYST SO HE STARTED TO PUSH THE PISTON TO GET THE BAG, HE INSERT THE SPECIMEN, WHEN THEY WERE STARTING TO PULL THE PISTON UP AND TAKE OFF THE GUIDE WIRE THE BAG STUCK IN THE TUBE HOLE. THE DOCTOR TRY SEVERAL TIME TO TAKE DOWN THE BAG AND SO USING STRENGTH THE BAG GET DOWN BUT THE PROBLEM IS THE ROUND GREEN GUIDE WIRE ON THE TOP THAT IS NOT MORE FIXED IN THE WIRE. THE PATIENT IS OK, BUT THE PROBLEM IS THE ROUND GREEN LITTLE BALL THAT ON THE WIRE GUIDE. THIS CAN FALL INTO THE ABDOMEN. THEY FORCED THE BAG FROM THE METAL TUBE AND IN SOME WAYS ( A LOT) THEY FINALLY CLOSETHE BAG AND TAKE IT AWAY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16APR25: I HAVE TWO STERILE SAMPLE OPENED FOR ME FROM THE 2 DIFFERENT BOXES TO VERIFY THE PROBLEM, THE THIRD SAMPLE ( THAT THEY USED IN THE OR) THEY GIVE ME ONLY THE PAPER REF BECAUSE THE SAMPLE WAS THREW IT AWAY AND THEY SHOW ME THIS ONE SAMPLE I MEAN ( WHAT I CAN SEE IS THE PAPER) BELONG TO ANOTHER BOX. SO TOTALLY THEY HAVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032278 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: CHOLECISTECTOMY. EVENT DESCRIPTION: DURING A CHOLECISTECTOMY DURING THE MOMENT TO CLOSE THE ENDOBAG WITH THE SPECIMEN INSIDE. THE DOCTOR START TO INSERT THE INZII TO PUT INSIDE THE CHOLECYST SO HE STARTED TO PUSH THE PISTON TO GET THE BAG, HE INSERT THE SPECIMEN, WHEN THEY WERE STARTING TO PULL THE PISTON UP AND TAKE OFF THE GUIDE WIRE THE BAG STUCK IN THE TUBE HOLE. THE DOCTOR TRY SEVERAL TIME TO TAKE DOWN THE BAG AND SO USING STRENGTH THE BAG GET DOWN BUT THE PROBLEM IS THE ROUND GREEN GUIDE WIRE ON THE TOP THAT IS NOT MORE FIXED IN THE WIRE. THE PATIENT IS OK, BUT THE PROBLEM IS THE ROUND GREEN LITTLE BALL THAT ON THE WIRE GUIDE. THIS CAN FALL INTO THE ABDOMEN. THEY FORCED THE BAG FROM THE METAL TUBE AND IN SOME WAYS (A LOT) THEY FINALLY CLOSETHE BAG AND TAKE IT AWAY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16APR25: I HAVE TWO STERILE SAMPLE OPENED FOR ME FROM THE 2 DIFFERENT BOXES TO VERIFY THE PROBLEM, THE THIRD SAMPLE (THAT THEY USED IN THE OPERATING ROOM (OR) THEY GIVE ME ONLY THE PAPER REF BECAUSE THE SAMPLE WAS THREW IT AWAY AND THEY SHOW ME THIS ONE SAMPLE I MEAN ( WHAT I CAN SEE IS THE PAPER) BELONG TO ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031898 ↗