Advincula Delineator Uterine Manipulator AD750SC-KE40Recalls & reported problems
Coopersurgical, Inc. · Advincula Delineator Uterine Manipulator with 4.0cm Soft Koh-Efficient · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937021370), received between Jul 17, 2023 and Jul 26, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K180429); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Entrapment of Device1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17396695 ↗MalfunctionJul 17, 2023Entrapment of Device
BALLOON FROM ADVINCULA DELINEATOR WAS REMOVED FROM THE MANIPULATOR AND LEFT IN THE PATIENT. RECOMMEND THAT THE BALLOON (PNEUMO OCCLUDER) NOT BE A DETACHABLE ITEM.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17331938 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K180429. One submission often covers many models, so check the product and lot details in each record.
- Z-1977-2019 · Jun 14, 2019 · TerminatedAdvincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed speci
- Z-1978-2019 · Jun 14, 2019 · TerminatedAdvincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed speci
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
- Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® AD750-KE35Coopersurgical, Inc. · Culdoscope (And Accessories)3 reports
- Arch Koh-Efficient KC-ARCH-30Coopersurgical, Inc. · Culdoscope (And Accessories)3 reports
- USA Series G27L-30WAGyrus ACMI, LLC · Culdoscope (And Accessories)3 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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