GelPOINT V-Path C2A15Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915138493), received between Oct 19, 2023 and Apr 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionOct 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: VNOTES HYSTERECTOMY +/- LAP BSO. EVENT DESCRIPTION: PATIENT IDENTIFIED AS A VERY NARROW VAGINAL OPENING AND SO DECISION TO USE C2A15 TO SUPPORT THE RING ENTRY OVER THEIR USUAL C2A12 FOR ALL VNOTES CASES. UNABLE TO CONTINUE VNOTES AFTER PERFORMING COLPOTOMY + USL SUSPENSION, THEN RING PLACEMENT AND INSUFFLATION AS VISION WASN'T THERE ONCE ENTERED. ISSUES WITH INSUFFLATION ON SECOND ATTEMPT. UNSTABLE. STOPPED EVERYTHING AND ONCE INSTRUMENTS AND CAMERA WERE REMOVED, UNCLIPPED THE CAP TO FIND A PLASTIC PART HAD FALLEN IN THE PATIENT. AFTER DECIDING THE SECOND ATTEMPT WAS UNSUCCESSFUL, SURGEONS ASKED TECH TO STOP THE GAS AND THEY REMOVED THEIR INSTRUMENTS, UNCLIPPED THE CAP, AND THAT WAS WHEN THE ASSISTANT SURGEON RECOGNIZED A CLEAR PIECE CAME OUT FROM HER AREA. THE ASSISTANT SURGEON CANNOT RECALL WHAT INSTRUMENT SHE HAD IN THE PORT BUT EITHER THE CAMERA OR REUSABLE GRASPER. MATCHING IT UP TO A MISSING PART OF THE TROCAR, ALL THE OTHER TROCARS WERE ASSESSED ENSURING NOTHING WAS LEFT IN THE PATIENT. ONLY ONE PLASTIC FOUND AND EVIDENT IT HAD COME FROM THE ONE TROCAR AS THEY COMPARED THEM SIDE BY SIDE WITH THE OTHERS AND RECOGNIZED THE DIFFERENCE IN LOOK/SHADE OF THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17971027 ↗