Inzii Retrieval System CD004Recalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 00607915126773), received between May 13, 2016 and Sep 9, 2026 — classified as 2 injuries, 155 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (43 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 157 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702243 ↗
• MalfunctionJul 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063859 ↗
• InjuryMay 21, 2026Break

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: THE COMPLAINT WAS GENERATED FROM MAUDE REPORT# MW5186077. INZII RETRIEVAL SYSTEM REF CD004, LOT#1564962 BROKE INSIDE THE PATIENT. ALL PIECES REMOVED. (B)(6). INTERVENTION: ALL PIECES REMOVED. PATIENT STATUS: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25247657 ↗
• MalfunctionApr 29, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: RARCX ROBOT ASSISTED RADICAL CYSTECTOMY. EVENT DESCRIPTION: WHEN CLOSING THE POUCH, THE STRING CAME LOOSE, BUT THE INSERTION DEVICE COULD NOT BE PULLED BACK. THE STRING APPEARS TO BE TANGLED, WHICH IS WHY THE KNOT WAS ALSO STUCK IN THE SHAFT. TYPE OF INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036833 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOT NEPHRECTOMY. EVENT DESCRIPTION: BAG DIDN'T LOCK WHEN LOOPING CORD WAS COMPLETELY PULLED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 11DEC25: SOME QUESTIONS WERE NOT ANSWERED BY THEM, SO THERE ARE SOME BLANKS. THEY COULDN¿T ANSWER THE QUESTIONS ABOUT THE LOCATION OF THE CORD BREAK RELATIVE TO THE BEAD. THIS IS BECAUSE THEY DON¿T KNOW WHAT THE BEAD IS. PATIENT STATUS (UNDER ANESTHESIA). USED AN EXTRA BAG AS INTERVENTION. YES, THE ACTUATOR ABLE TO BE FULLY RETRACTED BUT THE CORD WAS COMPLETELY TORN OUT OF THE BAG, LEAVING THE BAG COMPLETELY OPEN AND THEREFORE IMPOSSIBLE TO CLOSE. USED BY THE DOCTOR HIMSELF, USED NORMALLY. ADDITIONAL INFORMATION WAS RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17DEC25: CONFIRMED THE HOSPITAL HAD DISPOSED THE DEVICE. INTERVENTION: USED AN EXTRA BAG. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016191 ↗
• MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: DG. EVENT DESCRIPTION: FOLLOWING THE USUAL PROPER PROCEDURE, THE LEVER WAS PUSHED FORWARD AND THE BAG OPENED, BUT AT THE SAME TIME, GREEN BEADS FELL INTO THE ABDOMINAL CAVITY. THE BEADS USED TO CLOSE THE BAG REMAINED SEPARATE FROM THOSE THAT HAD FALLEN. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW PRODUCT AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918358 ↗
• MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC SALPINGECTOMY. EVENT DESCRIPTION: THE DRAWSTRING COMPLETELY DETACHED FROM THE BAG. IN RETURN THE BAG COULD NOT BE CLOSED, THEY OPENED A SECOND DEVICE. DR. WANTED TO GUIDE THE KIDNEY INTO THE BAG WHICH DID HAPPEN. HOWEVER, WHEN DR. WANTED TO CLOSE THE BAG THE DRAWSTRING DETACHED FROM THE BAG. OPENED UP ANOTHER BAG. ONLY A GRASPER TO GUIDE THE KIDNEY INTO THE BAG. INTERVENTION: OPENED UP ANOTHER BAG. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917764 ↗
• MalfunctionDec 22, 2025Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  PROCEDURE PERFORMED: ROBOT NEFRECTOMY. EVENT DESCRIPTION: LOOPING CORD BROKE OFF LOCKING MECHANISM DURING TIGHTENING/PULLING BAG. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 11DEC25: SOME QUESTIONS WERE NOT ANSWERED BY THEM, SO THERE ARE SOME BLANKS. THEY COULDN¿T ANSWER THE QUESTIONS ABOUT THE LOCATION OF THE CORD BREAK RELATIVE TO THE BEAD. THIS IS BECAUSE THEY DON¿T KNOW WHAT THE BEAD IS. PATIENT STATUS (UNDER ANESTHESIA). THERE WERE NO CORD FRAGMENT(S) THAT FELL INTO THE PATIENT. THE BREAK OCCURRED ON ONE SIDE WHERE IT IS ATTACHED TO THE GREEN ELEMENT. THE CORD HAD COME LOOSE ON ONE SIDE, PREVENTING THE BAG FROM CLOSING. ULTIMATELY THERE WAS SPILLAGE, EXTRA BAGS WERE USED TO REMOVE EVERYTHING FROM THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17DEC25: CONFIRMED THE HOSPITAL HAD DISPOSED THE DEVICE. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873835 ↗
• MalfunctionNov 25, 2025Premature Separation; Premature Separation

  PROCEDURE PERFORMED: GASTRECTOMY. EVENT DESCRIPTION: DURING THE PROCEDURE, THE DEVICE ENCOUNTERED SIGNIFICANT RESISTANCE WHEN ATTEMPTING TO DEPLOY THE SPECIMEN BAG. UPON APPLYING ADDITIONAL FORCE, THE BAG COMPLETELY DETACHED FROM THE SHAFT, RENDERING IT UNABLE TO BE UNFURLED OR USED. THERE IS NO IMPACT TO PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 10NOV2025: THE BAG COMPLETELY FELL OFF THE SUPPORTS, THE TIPS OF THE SUPPORTS EXPOSED INSIDE THE PATIENT. THE BAG FELL/PARTIALLY SLIPPED DOWN THE SUPPORTS DURING BAG MANIPULATION TO UNROLL THE BAG. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23651774 ↗
• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC NEPHRECTOMY. EVENT DESCRIPTION: WHEN WE WENT TO DEPLOY IT, THE METAL PIECE WENT INTO THE BAG. THE METAL PIECE WAS ON THE INSIDE AND THE STRING WAS BROKEN. THE PIECES DID FALL INTO THE PATIENT BUT THEY WERE ALL RETRIEVED. THE PRODUCT IS AVAILABLE FOR RETURN ONCE RISK MANAGEMENT RELEASES IT. INTERVENTION: USED A SECOND UNIT OF THE SAME LOT NUMBER AND IT WORKED PERFECTLY. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650437 ↗
• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC NEPHRECTOMY. EVENT DESCRIPTION: AFTER REMOVAL FROM BODY, WE NOTICED A PIECE OF THE BAG WAS MISSING, IT HAD SNAPPED FROM STRING OF BAG AND WAS LEFT IN THE PATIENT'S BODY. THE SURGEON HAD TO RE-INSUFFLATE THE PATIENT IN ORDER TO VISUALIZE THE MISSING PIECE AND RETRIEVE IT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 04NOV2025: THE BAG ITSELF WASN¿T DAMAGED, THERE WAS NO SPILLAGE AND THE BAG DIDN¿T BURST. PART OF THE GREEN PLASTIC ON THE INTRODUCER IS WHAT BROKE OFF, THIS IS A SAFETY ISSUE IF IT WAS TO FALL IN THE PATIENT. THE BAG WAS WRAPPED IN A RED BIOHAZARD BAG SO I COULDN¿T SEE EXACTLY WHERE IT BROKE BUT WILL HAVE IT SHIPPED BACK ONCE I RECEIVE A BOX. INTERVENTION: HAD TO INSUFFLATE AGAIN PATIENT TO REMOVE MISSING PIECE. PATIENT STATUS: PATIENT IS ALL GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649849 ↗
• MalfunctionNov 21, 2025Premature Separation; Premature Separation

  PROCEDURE PERFORMED: ROBOT-ASSISTED DISTAL GASTRECTOMY EVENT DESCRIPTION: "HOSPITAL [NAME] THIS IS A COMPLAINT FROM THE HOSPITAL; WHEN THE BAG WAS DEPLOYED, THE SUPPORT WIRE PROTRUDED FROM THE BAG, SO THE USER DETERMINED TO STOP USING THE EVENT UNIT AS IT IS NOT SAFE CONDITION. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY CD004 AND PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED." ADDITIONAL INFORMATION PROVIDED BY FI PERSONNEL VIA EMAIL ON (B)(6) 2025: THE SUPPORT TIPS WERE EXPOSED INSIDE THE PATIENT. INTERVENTION: AFTER CONFIRMING NO FRAGMENT DROPPED INTO THE ABDOMINAL CAVITY, REPLACED TO A HOSPITAL INVENTORY NEW CD004 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622553 ↗
• MalfunctionSep 5, 2025Premature Separation; Premature Separation

  PROCEDURE PERFORMED: ROBOT-ASSISTED GASTRECTOMY. EVENT DESCRIPTION: WHEN THE HANDLE WAS PUSH AND THE SPECIMEN BAG WAS DEPLOYED, THE SPECIMEN BAG AND SUPPORT WIRE WERE SEPARATED AT FIRST USE. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY CD004 AND PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED. ADDITIONAL INFORMATION RECEIVED 04SEP2025 BY EMAIL FROM AMJ RA/QA SPECIALIST: I GOT A RESPONSE FROM PIC INCLUDING THE ADDITIONAL INFORMATION AS BELOW. THE SUPPORT TIPS WERE EXPOSED INSIDE OF THE PATIENT. HOWEVER, THEY DID NOT CONTACT WITH ANY ORGANS AND ABDOMINAL WALL. THE DOCTOR THINKS THAT THE SUPPORT WIRE SUPPORT WIRE WAS NOT INSIDE THE SLIT IN THE POUCH, EVEN THOUGH IT SHOULD HAVE BEEN, SO THE ISSUE OCCURRED. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW CD004 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22981878 ↗
• MalfunctionSep 4, 2025Premature Separation; Premature Separation

  PROCEDURE PERFORMED: NEPHRECTOMY. EVENT DESCRIPTION: DURING DEPLOYMENT OF THE SPECIMEN RETRIEVAL BAG, WHEN THE USER ADVANCED THE THUMB RING TO EXPAND THE BAG, THE BAG DETACHED PREMATURELY FROM THE SUPPORT FRAME BEFORE FULL EXTENSION WAS ACHIEVED, REQUIRING REPLACEMENT WITH A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE IS NO IMPACT TO PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 14AUG2025: THE BAG COMPLETELY FELL OFF THE SUPPORTS AND THE TIPS OF THE SUPPORTS WERE EXPOSED INSIDE THE PATIENT. THE BAG FELL DOWN THE SUPPORTS DURING BAG MANIPULATION TO UNROLL THE BAG. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 18AUG2025: WHEN THE ACTUATOR WAS ADVANCED TO DEPLOY THE BAG, THE BAG DETACHED FROM THE SUPPORT FRAME. INTERVENTION: USER REPLACE WITH A NEW ONE. PATIENT STATUS: FINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968773 ↗
• MalfunctionSep 4, 2025Premature Separation; Premature Separation

  PROCEDURE PERFORMED: NEPHRECTOMY. EVENT DESCRIPTION: DURING DEPLOYMENT OF THE SPECIMEN RETRIEVAL BAG, WHEN THE USER ADVANCED THE THUMB RING TO EXPAND THE BAG, THE BAG DETACHED PREMATURELY FROM THE SUPPORT FRAME BEFORE FULL EXTENSION WAS ACHIEVED, REQUIRING REPLACEMENT WITH A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE IS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 14AUG2025: THE BAG COMPLETELY FELL OFF THE METAL SUPPORTS. THE TIPS OF THE SUPPORTS WERE NOT EXPOSED INSIDE THE PATIENT. THE BAG FELL DOWN THE SUPPORTS DURING BAG MANIPULATION TO UNROLL THE BAG. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 18AUG2025: WHEN THE ACTUATOR WAS ADVANCED TO DEPLOY THE BAG, THE BAG DETACHED FROM THE SUPPORT FRAME. INTERVENTION: USER REPLACE WITH A NEW ONE. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968206 ↗
• MalfunctionJun 20, 2025Break; Break

  PROCEDURE PERFORMED: NEPHRECTOMY. EVENT DESCRIPTION: WHEN SURGEON CLOSED THE BAG, THE DRAWSTRING SNAPPED OFF, AND BAG REOPENED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 05JUN2025: THE REP WAS ATTENDING THE CASE LATE AFTERNOON ON THE DAY IT OCCURRED. THE DRAWSTRING BROKE / SNAPPED WHERE IT LOOPS AROUND THE HOOK ON THE HANDLE. IT HAPPENED ABOVE THE GUIDE BEAD, THE KIDNEY DID FALL OUT THE BAG AGAIN, BUT DR OPENED ANOTHER BAG TO SECURE THE SPECIMEN. NO FRAGMENTS WERE FOUND IT WAS A CLEAN "SNAPPED" DRAWSTRING. WHEN THE DRAWSTRING BROKE WHERE IT LOOPS AROUND THE HOOK ON THE HANDLE, THE BAG INCLUDING THE STRING SLID OUT OF THE BARREL WHERE THE BAG IS ROLLED UP IN DUE TO THE SIZE OF THE KIDNEY. INTERVENTION: OPENED ANOTHER BAG. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302748 ↗
• MalfunctionJun 13, 2025Premature Separation; Premature Separation

  PROCEDURE PERFORMED: MYOMECTOMY EVENT DESCRIPTION: WHILE DEPLOYING THE BAG AND PREPARING TO PLACE THE SPECIMEN INSIDE, IT SUDDENLY DETACHED FROM THE PRONGS. THE HOSPITAL HAS ALREADY DISCARDED THE PRODUCT, AND IT IS NO LONGER RETRIEVABLE. UNFORTUNATELY, THE USER DID NOT TAKE ANY PHOTOS OF THE UNIT AT THE TIME OF THE INCIDENT. THERE IS NO IMPACT TO PATIENT. ADDITIONAL INFORMATION PROVIDED BY [DISTRIBUTOR] ON 15MAY2025: YES, THE BAG COMPLETELY FELL OFF THE METAL SUPPORTS. YES, THE TIPS OF THE SUPPORTS WERE EXPOSED INSIDE OF THE PATIENT. YES, THE BAG FELL DOWN THE SUPPORTS IMMEDIATELY UPON THE FULL DEPLOYMENT OF THE ACTUATOR. NO, THE ACTUATOR WAS NOT PUSHED FORWARD, RETRACTED, AND THEN FULLY DEPLOYED. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207440 ↗
• MalfunctionMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC NEPHRECTOMY. EVENT DESCRIPTION: CD004 WAS BEING USED TO REMOVE THE PATIENT'S KIDNEY, THE BAG HAD BEEN SUCCESSFULLY DEPLOYED AND THE TROCARS WERE BEING REMOVED READY TO REMOVE THE SPECIMEN WHEN THE EVENT OCCURRED. THE KIDNEY WAS PLACED IN THE BAG AND THE PATIENT WAS CHECKED FOR ANY BLEEDING BEFORE REMOVING ALL THE PORTS, THE RETRIEVAL STICK WAS UNHOOKED AND REMOVED FOLLOWED BY THE PORT IN WHICH THE GUIDE BEAD FELL OUT OF THE PORT IN TO THE SURGEONS HAND AS IT WAS BEING REMOVED WITH THE BAG STILL INSIDE THE PATIENT. THE PORT SITE INCISION WAS EXTENDED AND THE SPECIMEN WITHIN THE BAG WAS REMOVED. THE BAG STILL HAD THE SPECIMEN INSIDE THEREFORE ONCE THE INCISION WAS EXTENDED IT COULD BE REMOVED WITHOUT ANY INTERVENTION. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16MAY25: UNFORTUNATELY, NO VIDEO WAS TAKEN OF THE INCIDENT. INTERVENTION: THE BAG STILL HAD THE SPECIMEN INSIDE THEREFORE ONCE THE INCISION WAS EXTENDED IT COULD BE REMOVED WITHOUT ANY INTERVENTION. PATIENT STATUS: PATIENT STATUS IS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116639 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  PROCEDURE PERFORMED: NEPHRECTOMY. EVENT DESCRIPTION: WHEN PUSHING THE THUMB RING FORWARD TO DEPLOY THE BAG FROM THE INTRODUCER SHAFT, THE SUPPORT FRAME FULLY EXTENDED BUT A SIGNIFICANT PORTION OF THE BAG REMAINED TRAPPED WITHIN THE SHAFT, PREVENTING COMPLETE EXPANSION. THIS INSTRUMENT HAS ALREADY BEEN DISCARDED BY THE HOSPITAL. ADDITIONAL INFORMATION PROVIDED VIA EMAIL BY DISTRIBUTOR ON 28APR2025: SINCE THE INCIDENT OCCURRED LAST YEAR, THE CUSTOMER NO LONGER REMEMBERS WHETHER IT WAS DIFFICULT TO PUSH THE ACTUATOR AT THE TIME. ADDITIONAL INFORMATION PROVIDED VIA EMAIL BY DISTRIBUTOR ON 06MAY2025: UNFORTUNATELY, THE USER DISCARDED THE PHYSICAL ITEM, SO WE COULDN¿T TAKE PHOTOS OF IT. THEY ONLY CAPTURED THE MODEL AND BATCH NUMBER FROM THE STERILE PACKAGING. THE DISTAL PORTION OF THE BAG WAS STILL INSIDE THE SHAFT WHEN IT WAS REPORTED ¿A SIGNIFICANT PORTION OF THE BAG REMAINED TRAPPED WITHIN THE SHAFT." INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE. THERE IS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074905 ↗
• MalfunctionMay 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  PROCEDURE PERFORMED: GYNECOLOGIC LAPAROSCOPIC MINIMALLY INVASIVE SURGERY. EVENT DESCRIPTION: THE COMPLAINT WAS GENERATED FROM MEDWATCH REPORT # (B)(4) RECEIVED 02MAY2025. I WAS TOLD BY RN SCRUB THAT A PLASTIC PIECE ON THE TIP OF THE 12/15 BAG BROKE OFF INSIDE OF THE TROCAR. THE BROKEN PIECE WAS RETRIEVED (AND REMAINED IN THE TROCAR). THE ENDO CATCH BAG, BROKEN PIECE, AND CORRESPONDING WRAPPER WAS PLACED IN A BAG AND GIVEN TO MATERIALS MANAGEMENT PER THE GYN SLM [GYNECOLOGIC LAPAROSCOPIC MINIMALLY INVASIVE SURGERY]. FEMALE, 48 YRS, BLACK OR AFRICAN AMERICAN, EVENT DATE: APR 2025. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20MAY2025): BAG ITSELF DID NOT BREAK. PLASTIC PORTION BROKEN. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT, NOTHING IN PATIENT. NO BAG DID NOT BURST. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20MAY2025: THE TROCAR THAT WAS USED WITH AN INZII BAG IS NOT AVAILABLE FOR RETURN. INTERVENTION: ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT, PATIENT STATUS: NO PATIENT INJURY. PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074754 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  PROCEDURE PERFORMED: ABDOMINAL TOTAL HYSTERECTOMY. EVENT DESCRIPTION: DURING THE ATTEMPTED DEPLOYMENT OF THE BAG VIA ACTUATOR EXTENSION, THE BAG COMPLETELY DISLODGED FROM THE PRONGS AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY BEFORE THE PRONGS HAD FULLY EXTENDED BEYOND THE INTRODUCER SHEATH. ADDITIONAL INFORMATION OBTAINED FROM DISTRIBUTOR ON 30APR2025: THE TIPS OF THE SUPPORT WERE EXPOSED INSIDE THE PATIENT. THE BAG FELL DOWN THE SUPPORTS. THIS OCCURRED IMMEDIATELY UPON THE FULL DEPLOYMENT OF THE ACTUATOR. THE ACTUATOR WAS NOT PUSHED FORWARD, RETRACTED AND THEN FULLY DEPLOYED. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE. THERE IS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072179 ↗
• MalfunctionMay 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: RIGHT LOWER LOBECTOMY. EVENT DESCRIPTION: THE BAG WAS USED TO RETRIEVE THE LOBECTOMIE FROM THE CHEST CAVITY. DURING THE PULL OUT THE GUIDANCE BALL FELL INTO THE CAVITY AND GOT DETACHED FROM THE BAG. THE BAG WAS ALREADY DISPOSED OFF BEFORE THE BALL WAS FOUND, THEY KEPT THE BALL, AND ARE GOING TO CLEAN IT IF YOU NEED IT RETURNED. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER VIA EMAIL ON 10APR25: EVENT: CONTEXT OF LOWER LOBECTOMY BY VATS. DURING HAEMOSTASIS BY LYMPH NODE DISSECTION, THE SURGEON ACCIDENTALLY DISCOVERED THE GUIDE BALL IN THE PATIENT'S CHEST (THE STAFF HAD NOT NOTICED THIS WHEN THEY LEFT THE OPERATING ROOM). BALL REMOVED FROM THE PATIENT'S CHEST, NO EFFECT. THE GREEN BALL IN QUESTION IS AT THE PHARMACY IF NECESSARY FOR REFERRAL OR EXPERTISE. THE OTHER PART OF THE DEVICE WAS UNFORTUNATELY THROWN AWAY OR SENT TO THE ANATOMICAL PATHOLOGY LABORATORY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16APR25: THE BAG DIDN'T SEEM TO BE RIPPED IN ANY WAY OR AT LEAST RIPPED IN A WAY THAT AFFECTED THE PROCEDURE. ACTUALLY, THE SURGEON AND ANYONE THAT WAS THERE, INCLUDING MYSELF, DID NOT NOTICE THAT THE BEAD "BROKE" RIGHT UNTIL T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990195 ↗
• MalfunctionMay 6, 2025Material Rupture; Material Rupture

  PROCEDURE PERFORMED: LAPAROSCOPIC OVARIAN CYSTECTOMY. EVENT DESCRIPTION: THE BAG WAS BEING USED AS IT SHOULD BE, HAVING BEEN PLACED DOWN THE PORT TO RETRIEVE A LARGE DERMATOID CYST. THE EVENT OCCURRED DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, IN WHICH THE BAG BURST WHILST RETRIEVING A LARGE DERMATOID CYST. THE DEVICE WAS REPLACED WITH AN INZII UNIVERSAL BAG. INTERVENTION: THE DEVICE WAS REPLACED WITH AN INZII UNIVERSAL BAG. PATIENT STATUS: PATIENT IS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971937 ↗
• MalfunctionMay 2, 2025Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: ROBOTIC PARTIAL NEPHRECTOMY SURGERY. EVENT DESCRIPTION: DURING THE SURGERY, A GREEN BEAD WAS FOUND STUCK AT THE OPENING OF THE CTR33. AFTER THE USER REMOVED THE SPECIMEN BAG, THEY DISCOVERED THAT THE BEAD WAS BLOCKING THE BAG FROM BEING PROPERLY TIGHTENED. THE HOSPITAL HAS SINCE DISCARDED THE UNIT. THERE IS NO IMPACT TO PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 08APR2025 VIA EMAIL: WE WOULD LIKE TO INFORM YOU THAT AN ERROR OCCURRED IN THE PRODUCT MODEL DETAILS INITIALLY SUBMITTED, DUE TO INCORRECT INFORMATION PROVIDED BY THE SALES REPRESENTATIVE. WHILE THE PRODUCT BELONGS TO THE SAME CATEGORY, THE MODEL NUMBER AND SIZE WERE MISSTATED IN THE ORIGINAL COMPLAINT REPORT. PLEASE NOTE THAT THE MODEL NUMBER HAS BEEN UPDATED FROM CD001 TO CD004. PLEASE FIND ATTACHED THE CORRECTED VERSION OF THE COMPLAINT REPORT WITH THE ACCURATE PRODUCT MODEL INDICATED. BELOW ARE OUR RESPONSES TO YOUR QUESTIONS, WITH OUR REPLIES MARKED IN RED FOR YOUR REFERENCE. 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. THE GUIDE BEAD REMAINED ATTACHED TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954534 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: DA VINCI SYSTEM NEPHRECTOMY. EVENT DESCRIPTION: THE GREEN BEAD ON THE SPECIMEN BAG HAS COME OFF, MAKING IT UNABLE TO SECURELY CLOSE THE BAG. THIS INSTRUMENT HAS ALREADY BEEN DISCARDED BY THE HOSPITAL. THE HOSPITAL'S ABNORMAL MATERIAL REPORT HAS BEEN ATTACHED FOR REFERENCE. THERE IS NO IMPACT TO PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME]ON 01APR2025: SINCE THE BEAD FELL INTO THE SPECIMEN BAG, NO ACTION WAS TAKEN, AND THE BAG WAS PULLED OUT DIRECTLY. THE USER DID NOT TAKE A PHOTO AND CANNOT PROVIDE ONE. THE BEAD DID NOT FALL INSIDE THE PATIENT. THE BEAD COMPLETELY DETACHED FROM THE BAG. THE CORD IS IN NORMAL CONDITION. WHEN THE BAG WAS OPENED, THE BEAD BROKE AND FELL INTO THE SPECIMEN BAG. THERE WAS NO SPILLAGE OUT OF THE BAG OPENING. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20MAY2025: I¿VE REVIEWED THE REPLY YOU ATTACHED AND WOULD LIKE TO CLARIFY A SMALL MISUNDERSTANDING REGARDING THE ISSUE WE REPORTED. IN OUR ORIGINAL FEEDBACK, WE DID NOT MENTION THAT THE CORD HAD DETACHED OR COME OFF ENTIRELY. THE MAIN ISSUE THE USER OBSERVED WAS THAT THE GREEN BEAD ATTACHED TO THE CORD HAD CRACKED INTO PIECES AND WAS FOUND INSIDE THE BAG. THE CORD ITSELF REMAINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946036 ↗