GelPOINT V-PathRecalls & reported problems across all models

We found 3 models of GelPOINT V-Path by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2020 and Sep 22, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GelPOINT V-Path problems

GelPOINT V-Path models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GelPOINT V-Path C2A12

  Culdoscope (And Accessories)
  24 reports
• GelPOINT V-Path C2A15

  Culdoscope (And Accessories)
  4 reports
• GelPOINT V-Path C2A11

  Culdoscope (And Accessories)
  1 report

Recent GelPOINT V-Path adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionApr 6, 2026Difficult to Insert

  PROCEDURE PERFORMED: V-NOTES ADNEXAL SURGERY EVENT DESCRIPTION: DURING A V-NOTES ADNEXAL SURGERY, THE INTRODUCER WAS INSERTED THROUGH THE POUCH OF DOUGLAS AND THE RING WAS DEPLOYED. AT THAT TIME, BLEEDING WAS OBSERVED ON BOTH SIDES OF THE RECTAL MESENTERY. ACCORDING TO THE PHYSICIAN, THE BLEEDING ON THE LEFT SIDE MAY HAVE BEEN DUE TO A LACERATION, WHICH WAS SUTURED FOR HEMOSTASIS. IT WAS CONSIDERED THAT THE BLEEDING MAY HAVE BEEN CAUSED BY TENSION APPLIED TO THE RECTAL MESENTERY DURING DEPLOYMENT OF THE RING FROM THE INTRODUCER, RESULTING IN TISSUE INJURY. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED WITH A HOSPITAL INVENTORY, AND THE PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN NOT REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL NOT BE RETURNED. ADDITIONAL INFORMATION RECEIVED 16MAR2026 (FROM SALES REP) REGARDING THE CASE: PREOPERATIVE EVALUATION THE PATIENT WAS EVALUATED, AND IT WAS CONFIRMED THAT THE POUCH OF DOUGLAS WAS NOT OBLITERATED. ANATOMICAL CONSIDERATIONS THERE WERE NO SPECIFIC ANATOMICAL CHALLENGES REPORTED THAT WOULD HAVE MADE THE COLPOTOMY PARTICULARLY DIFFICULT (SUCH AS ADHESIONS, UNUSUAL DEPTH, OR ANGLE). COLPOTOMY TECHNIQUE AND DI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24795498 ↗
• MalfunctionMar 10, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: VNOTES EVENT DESCRIPTION: I WAS IN A VNOTES CASE TODAY AND I BELIEVE SOMETHING PLASTIC CAME OUT OF THE TROCAR FOR THE ATTACHED MODEL/LOT NUMBER DURING THE CASE. THEY WERE ABLE TO REMOVE THE PLASTIC PART WITHOUT ANY ISSUES BUT WANTED TO LET YOU KNOW. ADDITIONAL INFORMATION PROVIDED BY [COMPANY REP] ON 17FEB2026 VIA EMAIL: NO PATIENT INJURY. ENTIRE COMPONENT FELL OUT. YES, PIECES FELL INTO THE PATIENT. NO, THE TROCAR DID NOT SLIP DURING TORQUING. NO, THE SLEEVE WAS NOT REPOSITIONED. NO, THE PRODUCT IS NOT BEING RETURNED. THE PROCEDURE WENT WELL, THE VPATH WAS USED AND THEN DISPOSED OF. NEITHER REPLACEMENT NOR CREDIT. INTERVENTION: THEY WERE ABLE TO REMOVE THE PLASTIC PART WITHOUT ANY ISSUES. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565218 ↗
• 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 ↗
• MalfunctionFeb 5, 2025Use of Device Problem; Installation-Related Problem; Use of Device Problem; Installation-Related Problem

  PROCEDURE PERFORMED: SALPINGECTOMY. EVENT DESCRIPTION: DURING THIS SALPINGECTOMY CASE, UPON STARTING THE LAPAROSCOPIC PORTION, THE SURGEON NOTICED THE VIEW OF THE PELVIS WAS NOT WHAT WAS EXPECTED AS THE FALLOPIAN TUBES WERE NOT IN VIEW AND THE ALEXIS INNER RING SEEMED TO BE OFF-CENTER. THE ALEXIS WAS REMOVED AND REPLACED, USING THE INTRODUCER AND ROLLING THE INNER RING DOWN THREE TIMES, BUT THE SAME VIEW REMAINED. IT WAS DISCOVERED THAT THE PATIENT HAD A SMALL UTERUS, AND THE INNER RING WAS PLACED DEEP INTO THE ABDOMEN PAST THE UTERUS AND THE FALLOPIAN TUBES. THE ALEXIS WAS REPLACED AGAIN, USING THE INTRODUCER AND ROLLING THE INNER RING DOWN TWICE, BUT THE SAME VIEW REMAINED, AND THE UTERUS AND ADNEXA WERE CAUGHT BEHIND THE ALEXIS SHEATH. THE SURGEON USED A LAPAROSCOPIC GRASPER TO PULL BACK THE ALEXIS SHEATH BY GRABBING THE ANTERIOR INNER RING AND PULLING IT CLOSER SO THAT THE INNER RING SAT CLOSER TO THE CERVIX. THE INNER RING WAS NOT DIFFICULT TO MANIPULATE, AND THE UTERUS AND ADNEXA FELL OUT OF THE SPACE THEY WERE TRAPPED IN EASILY. THE SURGEON DID NOT PERFORM A TISSUE SWEEP ON THE FIRST INSERTION, BUT DID PERFORM A TISSUE SWEEP ON SUBSEQUENT ATTEMPTS. THE SURGEON NOTED THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318521 ↗

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