GelPOINT V-Path C2A12Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00607915138660), received between Dec 15, 2020 and Sep 22, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862585 ↗
• MalfunctionAug 7, 2026Detachment of Device or Device Component

  Procedure Performed: NI.Event Description: "The valve came off the trocar during the surgery and was found in the patient's abdomen"Impact of the problem: "Had to replace the material during surgery"Frequency of the problem: "First time."Type of Intervention: Had to replace the material during surgery.Patient Status: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180967 ↗
• MalfunctionJul 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060041 ↗
• MalfunctionJul 14, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25818883 ↗
• MalfunctionMay 1, 2026Entrapment of Device

  PROCEDURE PERFORMED: VNOTES. EVENT DESCRIPTION: I WANTED TO LET YOU ALL KNOW OF A VNOTES CASE ON (B)(6) 2026 WITH DR. [NAME] AT [HOSPITAL] WHERE TISSUE ENTRAPMENT OCCURRED. DR. [NAME] IDENTIFIED THAT TISSUE WAS TRAPPED AFTER PLACING THE V-PATH. THE SURGEON DECIDED TO FREE THE ENTRAPPED TISSUE WHILE THE V-PATH WAS PLACED USING SMOOTH BOWEL GRASPER MANIPULATION AND DIGITAL MANIPULATION WITH HER HANDS BETWEEN THE INNER RING AND THE PELVIC SIDEWALL. ONCE THE ENTRAPPED TISSUE WAS FREED, DR. [NAME] CONTINUED AND COMPLETED THE CASE VIA VNOTES. NO PATIENT INJURY WAS REPORTED. WE ARE REPORTING THIS AS A COMPLAINT BECAUSE ENTRAPMENT OCCURRED AND PULLING ENTRAPPED TISSUE FROM UNDER THE RETRACTED ALEXIS HAS THE POTENTIAL TO CAUSE TISSUE DAMAGE. ADDITIONAL INFORMATION PROVIDED BY [COMPANY REPRESENTATIVE] VIA EMAIL ON 30APR2026: TISSUE WAS TRAPPED BETWEEN THE INNER RING AND THE PELVIC SIDEWALLS. THERE WERE NO CHALLENGES WITH THE PATIENT'S ANATOMY, BUT THE V-PATH WAS PLACED POST-HYSTERECTOMY. TYPE OF INTERVENTION: ONCE THE ENTRAPPED TISSUE WAS FREED, DR. [NAME] CONTINUED AND COMPLETED THE CASE VIA VNOTES. PATIENT STATUS: NO CLINICAL IMPACT. THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062314 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: VNOTES EVENT DESCRIPTION: DURING CHANGING THE INSTRUMENTS, THE TROCAR BLOCKED. THEN THEY FOUND AN INSTRUMENT SHIELD IN THE PATIENT'S BODY, BY OPENING THE CAP. THEN THE TROCAR WAS NOT POSSIBLE TO USE ANYMORE. IN TOTAL 2 OF THE 3 TROCARS WHERE BLOCKED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA TEAMS CALL ON 11FEB26: BOTH THE SLEEVES WERE TAKEN OUT AND USED FROM THE SAME PACKAGE IN WHICH ONE SLEEVE BROKE AND THE OTHER SLEEVE BLOCKED. INTERVENTION: OPEN A NEW V-PATH C2A12. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369790 ↗
• MalfunctionNov 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: AI TRANSLATED: DURING SURGERY, THE PLASTIC TIP OF THE GELPOINT V-PATH DEVICE, REFERENCE (B)(4) FROM BATCH 1547987, DISCONNECTED FROM THE PLATFORM. NO SERIOUS CONSEQUENCES FOR THE PATIENT. RISK THAT THE DETACHED PLASTIC TIP COULD REMAIN LODGED IN THE PATIENT'S VAGINA. INTERVENTION: NI PATIENT STATUS: NO SERIOUS PATIENT CONSEQUENCES. RISK THAT THE DETACHED PLASTIC TIP COULD REMAIN LODGED IN THE PATIENT'S VAGINA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513670 ↗
• MalfunctionMar 28, 2025Installation-Related Problem; Installation-Related Problem

  PROCEDURE PERFORMED: VAGINAL HYSTERECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4) C2A12, LOT #UNK. COMPLAINT 2 OF 2: (B)(4) C2A12, LOT #UNK. THE SURGEON HAD COMPLETED A VAGINAL HYSTERECTOMY FOR A PATIENT WITH SEVERE STAGE 4 PROLAPSE AND INTENDED TO PLACE THE GELPOINT V-PATH POST-HYSTERECTOMY IN ORDER TO TAKE THE ADNEXA. SHE INSERTED THE DEVICE MANUALLY AND DID NOT PERFORM A TISSUE SWEEP PRIOR TO RETRACTING THE OUTER RING OF THE ALEXIS 3 TIMES. THE SURGEON ASSEMBLED THE DEVICE, ESTABLISHED PNEUMOPERITONEUM, AND INSERTED HER LAPAROSCOPIC INSTRUMENTATION. THE SURGEON NOTED THAT THE PATIENT'S RIGHT TUBE AND OVARY WERE TRAPPED BEHIND THE INNER RING OF THE ALEXIS. THE SURGEON UNROLLED THE OUTER RING OF THE ALEXIS AND REMOVED THE DEVICE, THEN REPLACED AGAIN MANUALLY. THE SURGEON DID NOT PERFORM A TISSUE SWEEP PRIOR TO RETRACTING THE OUTER RING OF THE ALEXIS 4 TIMES. UPON ENTERING LAPAROSCOPICALLY, THE SURGEON ONCE AGAIN NOTED ENTRAPMENT OF THE PATIENT'S RIGHT TUBE AND OVARY. SHE ATTEMPTED TO PULL EXTERNALLY ON THE LEFT SIDE OF THE ALEXIS SHEATH TO FREE THE TISSUE, BUT WAS UNSUCCESSFUL. SHE UNROLLED THE OUTER RING OF THE ALEXIS AND REMOVED THE DEVICE. SHE REPLACED IT AGAIN MANUALLY AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720408 ↗
• MalfunctionMar 28, 2025Installation-Related Problem; Installation-Related Problem

  PROCEDURE PERFORMED: VAGINAL HYSTERECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4), LOT #UNK. COMPLAINT 2 OF 2: (B)(4), LOT #UNK. THE SURGEON HAD COMPLETED A VAGINAL HYSTERECTOMY FOR A PATIENT WITH SEVERE STAGE 4 PROLAPSE AND INTENDED TO PLACE THE GELPOINT V-PATH POST-HYSTERECTOMY IN ORDER TO TAKE THE ADNEXA. SHE INSERTED THE DEVICE MANUALLY AND DID NOT PERFORM A TISSUE SWEEP PRIOR TO RETRACTING THE OUTER RING OF THE ALEXIS 3 TIMES. THE SURGEON ASSEMBLED THE DEVICE, ESTABLISHED PNEUMOPERITONEUM, AND INSERTED HER LAPAROSCOPIC INSTRUMENTATION. THE SURGEON NOTED THAT THE PATIENT'S RIGHT TUBE AND OVARY WERE TRAPPED BEHIND THE INNER RING OF THE ALEXIS. THE SURGEON UNROLLED THE OUTER RING OF THE ALEXIS AND REMOVED THE DEVICE, THEN REPLACED AGAIN MANUALLY. THE SURGEON DID NOT PERFORM A TISSUE SWEEP PRIOR TO RETRACTING THE OUTER RING OF THE ALEXIS 4 TIMES. UPON ENTERING LAPAROSCOPICALLY, THE SURGEON ONCE AGAIN NOTED ENTRAPMENT OF THE PATIENT'S RIGHT TUBE AND OVARY. SHE ATTEMPTED TO PULL EXTERNALLY ON THE LEFT SIDE OF THE ALEXIS SHEATH TO FREE THE TISSUE BUT WAS UNSUCCESSFUL. SHE UNROLLED THE OUTER RING OF THE ALEXIS AND REMOVED THE DEVICE. SHE REPLACED IT AGAIN MANUALLY AND DID NOT PER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720399 ↗
• MalfunctionMar 7, 2025Malposition of Device; Malposition of Device

  PROCEDURE PERFORMED: HYSTERECTOMY, BSO CASE. EVENT DESCRIPTION: FEEDBACK SUBMISSION - COMPLAINT NOTIFICATION - (B)(4). DURING THIS HYSTERECTOMY, BSO CASE THE PATIENT'S LEFT FALLOPIAN TUBE WAS CAUGHT BEHIND THE INNER RING OF THE ALEXIS. THE SURGEON DID NOT PERFORM A TISSUE SWEEP AFTER INSERTING THE ALEXIS AND DID NOT BECOME AWARE THAT THE LEFT FALLOPIAN TUBE WAS TRAPPED BEHIND THE INNER RING UNTIL TOWARD THE END OF THE PROCEDURE. THE SURGEON HAD ALREADY MOBILIZED THE UTERUS AND RIGHT FALLOPIAN TUBE WHEN HE NOTICED THE LEFT TUBE WAS TRAPPED WHEN LOOKING FOR THAT STRUCTURE. A VERY SMALL PORTION OF THE LEFT TUBE WAS STICKING OUT BEYOND THE RING, AND THE SURGEON ATTEMPTED TO GRAB THE TUBE WITH HIS LAPAROSCOPIC GRASPER, BUT THIS WAS UNSUCCESSFUL. THE SURGEON THEN TRIED TO REPOSITION THE ENTIRE PLATFORM IN MULTIPLE DIRECTIONS WHILE STILL GRASPING THE TUBE UNDER TENSION TO ATTEMPT TO FREE IT, WHICH WAS ALSO UNSUCCESSFUL. THE CLINICAL EDUCATION SPECIALIST PRESENT AT THE CASE SUGGESTED REMOVING THE GELSEAL CAP AND PERFORMING A FINGER SWEEP TO FREE THE TUBE, BUT THIS WAS UNSUCCESSFUL. THE CES ALSO RECOMMENDED UNROLLING THE ALEXIS TO RELIEVE SOME TENSION, BUT THE SURGEON DECIDED INSTEAD TO COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554461 ↗
• MalfunctionFeb 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: VNOTES EVENT DESCRIPTION: [HOSPITAL] REPORT FROM THE SALES REP VIA EMAIL; THE TRANSPARENT VALVE OF THE SLEEVE FELL INTO THE BODY WHEN THE FORCEPS WAS INSERTED THROUGH THE SLEEVE AND WAS RETRIEVED. THIS UNIT WILL BE RETURNED(CLEAR PARTS ONLY). INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW C2A12 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 21335573 ↗
• MalfunctionFeb 7, 2025Use of Device Problem; Use of Device Problem

  PROCEDURE PERFORMED: HYSTERECTOMY, BSO. EVENT DESCRIPTION: THIS WAS A HYSTERECTOMY, BSO CASE THAT WAS CONVERTED TO A TRADITIONAL VAGINAL APPROACH. THE PATIENT HAD SIGNIFICANT PROLAPSE AND THE SURGEON STRUGGLED TO CREATE THE ANTERIOR COLPOTOMY AS WELL AS SEAT THE ALEXIS RING. THE SURGEON DECIDED TO REMOVE THE UTERUS VAGINALLY AND COMPLETE THE BSO PORTION OF THE PROCEDURE VIA VNOTES. UPON INSERTING THE ALEXIS, THE INNER RING CAUGHT THE PATIENT'S LEFT OVARY, AND IT WAS STUCK UNDER THE RING. THE SURGEON HAD TO FISH OUT THE LEFT OVARY FROM UNDER THE ALEXIS SHEATH. THE SURGEON DID NOT PERFORM A TISSUE SWEEP AFTER INSERTING THE INNER RING OF THE ALEXIS BUT DID PERFORM A VISUAL INSPECTION AFTER PLACING THE GELSEAL CAP AND VISUALIZED THE OVARY BEING CAUGHT. THE SURGEON WAS ABLE TO REMOVE IT AND COMPLETE THE CASE WITHOUT INJURY TO THE PATIENT. THE CASE WAS SUCCESSFULLY COMPLETED VIA VNOTES. ADDITIONAL INFORMATION OBTAINED FROM [NAME] VIA EMAIL ON 31JAN2025: THE EVENT DATE FOR THIS CASE WAS 12/17/24. ADDITIONAL INFORMATION OBTAINED FROM [ACCOUNT MANAGER] VIA PHONE CALL ON 05FEB2025: THERE WAS NO INJURY TO THE PATIENT. THE PATIENT'S ANATOMY DID NOT POSE ANY CHALLENGES WHILE PLACING THE ALEXIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333927 ↗
• MalfunctionJan 28, 2025Installation-Related Problem; Installation-Related Problem

  PROCEDURE PERFORMED: HYSTERECTOMY, BSO, USLS. EVENT DESCRIPTION: FOR THIS CASE VNOTES WAS PERFORMED POST HYSTERECTOMY AS THE PATIENT HAD SEVERE PROLAPSE. THE V-PATH WAS PLACED TO PERFORM THE BSO/USLS PORTION OF THE PROCEDURE. UPON LAPAROSCOPIC ENTRY, THE SURGEON VISUALIZED THE RIGHT FALLOPIAN TUBE COVERED BY THE ALEXIS SHEATH. THE APS PRESENT AT THE CASE VERIFIED THAT THE SURGEON DID PERFORM A TISSUE SWEEP AFTER PLACING THE DEVICE AND PRIOR TO STARTING THE LAPAROSCOPIC PORTION OF THE PROCEDURE. THE SURGEON USED LAPAROSCOPIC GRASPERS TO EXPOSE THE TUBE. THERE WAS NO PATIENT INJURY AS A RESULT OF ENTRAPMENT AND NO FURTHER ISSUES THROUGHOUT THE CASE. THE CASE WAS SUCCESSFULLY COMPLETED VIA VNOTES. SUMMARY: VNOTES POST HYST, TISSUE ENTRAPMENT. ADDITIONAL INFORMATION PROVIDED ON 06JAN2025 BY [NAME]. THERE WAS INTERNAL TISSUE ENTRAPMENT. YES, THE SURGEON PERFORMED A TISSUE SWEEP BEFORE AND AFTER ROLLING DOWN THE ALEXIS TO CHECK FOR TISSUE ENTRAPMENT. YES, THE TISSUE SWEEP WAS DONE FOR BOTH INNER AND OUTER RING OF (B)(6). THE SURGEON RESOLVED THE ISSUE BY USING A GRASPER TO GET THE TUBE OUT FROM UNDERNEATH THE SHEATH. NO, THERE WERE NO CHALLENGES WITH THE PATIENT'S ANATOMY. THERE WAS NO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260768 ↗
• MalfunctionJan 28, 2025Installation-Related Problem; Installation-Related Problem

  PROCEDURE PERFORMED: HYSTERECTOMY, BSO, USLS. EVENT DESCRIPTION: FOR THIS CASE VNOTES WAS PERFORMED POST HYSTERECTOMY AS THE PATIENT HAD SEVERE PROLAPSE. THE V-PATH WAS PLACED TO PERFORM THE BSO/USLS PORTION OF THE PROCEDURE. UPON LAPAROSCOPIC ENTRY, THE SURGEON VISUALIZED THE RIGHT FALLOPIAN TUBE COVERED BY THE ALEXIS SHEATH. THE APS PRESENT AT THE CASE VERIFIED THAT THE SURGEON DID PERFORM A TISSUE SWEEP AFTER PLACING THE DEVICE AND PRIOR TO STARTING THE LAPAROSCOPIC PORTION OF THE PROCEDURE. THE SURGEON USED LAPAROSCOPIC GRASPERS TO EXPOSE THE TUBE. THERE WAS NO PATIENT INJURY AS A RESULT OF ENTRAPMENT AND NO FURTHER ISSUES THROUGHOUT THE CASE. THE CASE WAS SUCCESSFULLY COMPLETED VIA VNOTES. ADDITIONAL INFORMATION PROVIDED ON 06JAN2025 BY [NAME] THERE WAS INTERNAL TISSUE ENTRAPMENT. YES, THE SURGEON PERFORMED A TISSUE SWEEP BEFORE AND AFTER ROLLING DOWN THE ALEXIS TO CHECK FOR TISSUE ENTRAPMENT. YES, THE TISSUE SWEEP WAS DONE FOR BOTH INNER AND OUTER RING OF ALEXIS. THE SURGEON RESOLVED THE ISSUE BY USING A GRASPER TO GET THE TUBE OUT FROM UNDERNEATH THE SHEATH. NO, THERE WERE NO CHALLENGES WITH THE PATIENT'S ANATOMY. THERE WAS NO PATIENT INJURY CAUSED BY TISSUE ENTRAPMENT. A GR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260761 ↗
• MalfunctionDec 11, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: VNOTES HYSTERECTOMY. DETAILED DESCRIPTION OF EVENT: HOSPITAL: [FACILITY], MODEL #: C2A12, LOT #: 1527639. THE MEDICAL DEVICE WAS OPENED DURING SURGERY. THE NURSE NOTICED A HOLE IN THE PACKAGING AFTER THE DEVICE WAS OPENED AND BEFORE IT WAS ABOUT TO BE USED ON THE PATIENT. THE DEVICE WAS NOT USED, AND THE PROCEDURE SWITCHED TO LAPAROSCOPIC DUE TO THE PATIENT'S ANATOMY. THE PRODUCT AND ITS PACKAGING WILL RETURN TO AMR. THE ACCOUNT MANAGER WILL PROVIDE A PICTURE OF THE PACKAGING. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 05DEC2024 VIA EMAIL: TO SPECIFY. THE CIRCULATOR NURSE OPENED THE OUTER PEEL PACK AS THE SCRUB TECH REACHED IN TO REMOVE THE PLASTIC PACKAGING THAT CONTAINED ALL THE COMPONENTS. AT THAT POINT THE CIRCULATOR WAS CHECKING THE PACKAGING SHE PEELED OPEN AND FOUND A HOLE IN THAT PEEL PACK, AND THEN DIRECTED THE SCRUB TECH NOT TO OPEN THE REMAINING PLASTIC PACKAGING AND TO HAND IT OFF. MY REASON FOR BRINGING THIS UP IS THAT THERE IS NO REASON TO STERILIZE THE PRODUCT BEFORE RETURNING TO RSM. IT WAS NEVER REMOVED FROM THE INNER PLASTIC CONTAINER PACKAGING. SO, THEY WILL BE RETURNING THE UNOPENED PLASTIC PACKAGING, THE DAMAGED PEEL PACK PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906848 ↗
• MalfunctionDec 10, 2024Installation-Related Problem; Installation-Related Problem

  PROCEDURE PERFORMED: HYSTERECTOMY AND SALPINGECTOMY. EVENT DESCRIPTION: FEEDBACK 7169 DURING THIS HYSTERECTOMY, SALPINGECTOMY CASE THE PATIENT'S LEFT FALLOPIAN TUBE WAS CAUGHT BEHIND THE INNER ALEXIS RING. THE SURGEON DID NOT PERFORM A TISSUE SWEEP AFTER INSERTING THE DEVICE TO ENSURE THERE WAS NO TISSUE ENTRAPMENT. THE SURGEON ALSO DID NOT CONFIRM THE LOCATION OF THE FALLOPIAN TUBES WITH A SCOPE PRIOR TO STARTING RESECTION, AS THEY DID NOT KNOW THE LEFT FALLOPIAN TUBE WAS ENTRAPPED UNTIL AFTER THE UTERUS AND RIGHT FALLOPIAN TUBE HAD BEEN REMOVED. THE SURGEON THEN REMOVED THE V-PATH DEVICE TO FREE THE LEFT FALLOPIAN TUBE AND THEN PROCEEDED TO REMOVE IT VAGINALLY. THE LEFT FALLOPIAN TUBE WAS HANGING VERY LOW, AND THIS WAS LIKELY THE REASON IT WAS CAUGHT BEHIND THE RING, BUT IT DID NOT CAUSE ANY PROBLEMS THROUGHOUT THE PROCEDURE. ADDITIONAL INFORMATION OBTAINED FROM [NAME] ON 27NOV2024 NO OTHER DEVICES WERE USED. I DON'T HAVE THE LOT NUMBER AND THE PRODUCT IS NOT BEING RETURNED. THE SURGEON DIDN'T THINK THERE WAS ANYTHING WRONG WITH THE PRODUCT DURING THIS PROCEDURE. THE PATIENT'S FALLOPIAN TUBE WAS JUST LOWER THAN NORMAL. NO CLOSING REPORT WAS REQUESTED AND THERE WAS NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897403 ↗
• MalfunctionJul 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: VNOTES. EVENT DESCRIPTION: [HOSPITAL]. THERE IS A SMALL CLEAR PLASTIC SEAL INSIDE OF THE VNOTES PORT. AS THE SURGEON WAS PASSING THE SUTURE THROUGH THE PORT THE NEEDLE CAUGHT ON THE PLASTIC SEAL AND YANKED IT INTO THE PATIENT'S BODY CAVITY. THE SURGEON SAW IT AND REMOVED IT FROM THE BODY. THE DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE CASE. THE LOT NUMBER OF THE DEVICE IS UNKNOWN. NO PATIENT INJURY OCCURRED. THE DEVICE WAS DISCARDED AFTER USE, HOWEVER THE CLEAR PLASTIC PIECE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM [NAME] VIA EMAIL ON 24JUL2024: [HOSPITAL] NOW ORDERS THROUGH A WAREHOUSE, THE ID CODE IS: 1030563. TYPE OF INTERVENTION: REPLACED WITH ANOTHER DEVICE (SAME MODEL) TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856073 ↗
• MalfunctionJun 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HYSTERECTOMY W/ BSO AND USLS EVENT DESCRIPTION: COMPLAINT CREATED BASED OFF FEEDBACK 5442. SUBMITTED 11MAY2023. AT THE END OF THE PROCEDURE, THE SURGEON PULLED THE GELSEAL CAP OFF AND NOTICED THAT A SUTURING NEEDLE HAD SNAGGED THE SEAL OF THE TROCAR. THE SEAL CAME OFF DURING DISASSEMBLY. THE APS AT THE CASE, [NAME], NOTED THAT THIS INCIDENT OCCURRED AT THE END OF THE PROCEDURE AND THAT THERE WERE NO ISSUES PRIOR TO DISCOVERING THE SEAL. SHE ADDITIONALLY DID NOT NOTICE ANYTHING UNUSUAL WHEN THE SURGEON INSERTED THE NEEDLE THROUGH THE TROCAR SLEEVE. ADDITIONAL INFORMATION RECEIVED ON 23MAY2023 VIA EMAIL FROM [NAME], CLINICAL EDUCATION SPECIALIST NO PATIENT INJURY OCCURRED. THE SEAL WAS NOTICED DURING DISASSEMBLY TO HAVE COME OFF AT SOME POINT IN THE PROCEDURE. INTERVENTION: CASE WAS COMPLETED WITH THE SAME DEVICE. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083920 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HYSTERECTOMY WITH DOUBLE ADNEXECTOMY, MYOMATOUS UTERUS. EVENT DESCRIPTION: THE REVISION OF THE CAVITY WAS BEING CARRIED OUT, AFTER REMOVING THE UTERUS AND ANNEXES, AT THAT MOMENT IT WAS DISCOVERED THAT PART OF THE TROCAR SEAL WAS LOOSE INSIDE. THE PART OF THE TROCAR THAT HAS DETACHED (INNER WHITE PLASTIC SEAL) IS REMOVED, A PHOTO OF THE PRODUCTS IS ATTACHED. THE DEFECTIVE TROCAR IS USED DURING THE ENTIRE INTERVENTION FOR OPTICS IN THE SIX O´CLOCK POSITION. THE HOSPITAL DOCUMENTS THE CASE JUST BY SENDING A PHOTO AND DISCARDS THE DEVICE. INTERVENTION: THE PART OF THE TROCAR THAT HAS DETACHED (INNER WHITE PLASTIC SEAL) IS REMOVED. PATIENT STATUS: FAVORABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615281 ↗
• MalfunctionJan 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NOTES HYSTERECTOMY EVENT DESCRIPTION: PLASTIC PIECE FROM TROCAR SEAL FELL INTO PATIENT DURING DEVICE USE. THE PHYSICIAN REMOVED THE PLASTIC PIECE TO COMPLETE THE CASE. NO PATIENT INJURY OCCURRED. PLASTIC PIECE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 15SEP2022 VIA EMAIL FROM [NAME], ACCOUNT MANAGER: THE INSTRUMENT BEING USED WAS A NEEDLE HOLDER. ADDITIONAL INFORMATION RECEIVED ON 15 SEP2022 VIA EMAIL FROM [NAME] ACCOUNT MANAGER: THE PLASTIC PIECE REPORTED BY THE CUSTOMER WAS A FRAGMENT. INTERVENTION: THE PHYSICIAN REMOVED THE PLASTIC PIECE TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134432 ↗
• MalfunctionJul 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  NAME OF PROCEDURE PERFORMED: HYSTERECTOMY EVENT DESCRIPTION: [TRANSLATION] A PIECE OF PLASTIC FROM THE VNOTE VALVE HAS COME OFF (TRANSPARENT). FOUND IN THE PATIENT'S VAGINA. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 29JUNE22: NAME OF PROCEDURE BEING PERFORMED WAS HYSTERECTOMY .PATIENT STATUS IS OK. THE VALVE DID SEPARATE FROM THE SEAL HE DOESN'T KNOW IF AN ENTIRE COMPONENT FALL OUT OR IF IT DID APPEAR TO BE TORN ALL MATERIAL WAS RETRIEVED FROM THE PATIENT HE DOESN'T KNOW IF ANY INSTRUMENTS WERE INSERTED THROUGH THE TROCAR AT THE TIME OF THE EVENT HE DOESN'T KNOW IF ANYTHING OTHER THAN INSTRUMENTATION WAS PLACED THROUGH THE TROCAR [ORIGINAL]. INTERVENTION ALL MATERIAL WAS RETRIEVED FROM THE PATIENT. PATIENT STATUS: OK. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021220 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: VNOTES HYSTERECTOMY + USLS. EVENT DESCRIPTION: "DURING THE SURGERY, WHEN THE DR. INSERTED A 40 SIZE NEEDLE TO PERFORM THE USLS PROCEDURE, THE INNER INSTRUMENT SHIELD (PLASTIC RING SIMILAR TO THE BIG INSTRUMENT SHIELD) OF THE 10MM TROCAR SLIPPED OUT OF THE TROCAR AND SLIDED ONTO THE INSTRUMENT. THE DR.'S ANALYSIS IS THAT HE MIGHT HAVE HIT IT WHEN INSERTING THE NEEDLE INTO THE TROCAR AS IT WAS A BIG NEEDLE (SIZE 40)". ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 24-MAR-22: THE ENTIRE COMPONENT FELL OUT. THE INSTRUMENT THAT WAS INSERTED IN THE TROCAR WAS A NEEDLE HOLDER WITH A SIZE 40 NEEDLE TO PERFORM THE USLS PROCEDURE ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06-APR-22 FROM APPLIED MEDICAL PRODUCT MGR: THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE EVENT. THERE WAS NO EFFECT ON PATIENT. PATIENT STATUS: THERE WAS NO EFFECT ON PATIENT. TYPE OF INTERVENTION: THE DR. HAD TO OPEN THE GEL SEAL CAP AND REMOVE THE SMALL PLASTIC INSTRUMENT SHIELD FROM THE INSTRUMENT AND THEN REATTACHED THE GEL SEAL CAP AND CONTINUED THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079155 ↗
• MalfunctionMar 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: VNOTES WORKSHOP. EVENT DESCRIPTION: CER FROM VNOTES WORKSHOP. THE FOLLOWING INFORMATION WAS PROVIDED ON 18 FEBRUARY VIA EMAIL BY [NAME]: I NEED TO UPDATE YOU ON A PRODUCT ISSUE. I RAN A VNOTES WORKSHOP TODAY IN ADELAIDE WITH [NAME] AND [NAME] AS FACULTY. [NAME] WAS TEACHING A COUPLE OF CONSULTANTS WITH OUR GELPOINT VPATH WHEN A SUTURE (SEE FIRST PICTURE BELOW FOR DETAILS) WAS INTRODUCED INTO ONE OF THE 10MM SLEEVES, AND PART OF THE DEVICE POPPED OUT AND INTO THE SIMSEI. [NAME] IS CONCERNED AS THE PLASTIC WAS PUSHED OUT FROM THE SLEEVES. PATIENT STATUS: NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796220 ↗
• MalfunctionDec 15, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: VNOTES HYSTERECTOMY. DESCRIPTION TRANSCRIBED FROM TELEPHONE CALL WITH APPLIED MEDICAL REPRESENTATIVE 23NOV20: POLYURETHANE SHEATH HAS PARTIALLY SEPARATED FROM THE PLACEMENT RING DURING VNOTES PROCEDURE. THE DAMAGED ALEXIS WAS REMOVED, AND A NEW PRODUCT WAS OPENED - THE PROCEDURE WAS COMPLETED USING THE ALEXIS FROM THE SECOND PACKAGE BUT THE ORIGINAL GELPORT WAS USED. NO CONSEQUENCES OR INJURY FOR PATIENT. THE TEAR OCCURRED FROM BOTTOM OF SHEATH AT THE RING, THE TEAR WAS APPROXIMATELY 2 INCHES IN DIAMETER. THE PRODUCT IS IN THEATRES 2 IN QUARANTINE. PATIENT STATUS: NO CONSEQUENCES OR INJURY TO THE PATIENT. TYPE OF INTERVENTION: CHANGE OF DEVICE: ALEXIS COMPONENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11009011 ↗