GelPOINT V-Path C2A11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915138486), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping

  PROCEDURE PERFORMED: VNOTES HYSTERECTOMY W/ BILATERAL SALPINGECTOMY. EVENT DESCRIPTION: [HOSPITAL]. THE STAFF OPENED THE DEVICE AND UPON INSERTING THE TROCAR, THEY NOTICED A HAIR ON THE DEVICE. STAFF DID NOT SEE/NOTICE THE HAIR WHEN OPENING THE ORIGINAL PACKAGING. THE SURGEON NOTICED WHEN INSERTING THE TROCAR. STAFF/SURGEONS DID STATE THAT THEY AREN'T SURE WHERE THE HAIR CAME FROM, BUT TO BE SAFE THEY WANTED TO OPEN A NEW DEVICE. A NEW DEVICE WAS OPEN AND THIS DEVICE WAS DISCARDED. THE LOT NUMBER WAS 1487502. THE PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM [NAME] VIA EMAIL ON 30SEP2024: NO PATIENT INJURY OR ILLNESS OCCURRED. DATE OF THE EVENT WAS 9/27/2024. THE REP WAS PRESENT DURING THE CASE. THE PROCEDURE PERFORMED WAS A VNOTES HYSTERECTOMY W/ BILATERAL SALPINGECTOMY. ADDITIONAL INFORMATION RECEIVED FROM [NAME] VIA EMAIL ON 30SEP2024: HOSPITAL CONTACT IS [NAME AND EMAIL]. INTERVENTION: A NEW DEVICE WAS OPEN AND THIS DEVICE WAS DISCARDED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537947 ↗