Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® AD750-KE35Recalls & reported problems
Coopersurgical, Inc. · Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888937012750), received between Nov 11, 2025 and May 27, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Unintended Movement1
Patient problems
- Laceration(s)2
- Uterine Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Unintended Movement
IT WAS REPORTED THAT DURING A LAPERSCOPIC HYSTERECTOMY, THE SURGEON INSERTED THE DELINEATOR AND SNAPPED THE POSITION LOCK IN PLACE. DURING THE PROCEDURE, THE 3RD YEAR RESIDENT PHYSICIAN WAS PUSHING CEPHALAD VERY FIRMLY ON THE DELINEATOR. THE DELINEATOR TIP PERFORATED THE UTERUS BETWEEN THE FUNDUS AND CERVIX. THE RESIDENT PHYSICIAN SAID THE POSITION LOCK SLIPPED, CAUSING THE COLPOTOMY CUP TO SHIFT, RESULTING IN A PERFORATION. NO INJURIES RESULTED. PROCEDURE RESUMED. AD750-KE35 UTERINE MANIPULATOR 2026-05-0000074.
Patient problems: Uterine Perforation
MAUDE report 25306943 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY, THE PATIENT EXPERIENCED A VAGINAL LACERATION. IN ADDITION TO THE DELINEATOR, THE ALLY II UPS WAS BEING UTILIZED DURING THE PROCEDURE. LACERATION WAS SUTURED, VAGINAL PACKING WAS PLACED AND THE PATIENT WAS STABLE. AD750-KE35 KOH-EFF 2025-10-0000457.
Patient problems: Laceration(s)
MAUDE report 23522118 ↗
Other Culdoscope (And Accessories) devices
- GelPOINT V-Path C2A12Applied Medical Resources Corporation · Culdoscope (And Accessories)24 reports
- RUMI II Koh-Efficient KC-RUMI-30Coopersurgical, Inc. · Culdoscope (And Accessories)12 reports
- RUMI II Koh-Efficient KC-RUMI-35Coopersurgical, Inc. · Culdoscope (And Accessories)8 reports
- Arch Koh-Efficient KC-ARCH-35Coopersurgical, Inc. · Culdoscope (And Accessories)4 reports
- GelPOINT V-Path C2A15Applied Medical Resources Corporation · Culdoscope (And Accessories)4 reports
- Arch Koh-Efficient KC-ARCH-30Coopersurgical, Inc. · Culdoscope (And Accessories)3 reports
- USA Series G27L-30WAGyrus ACMI, LLC · Culdoscope (And Accessories)3 reports
- Advincula Delineator Uterine Manipulator AD750SC-KE40Coopersurgical, Inc. · Culdoscope (And Accessories)2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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