Arch Koh-Efficient KC-ARCH-35Recalls & reported problems
Coopersurgical, Inc. · Arch Koh-Efficient - 3.5 cm- Medium- for use with Advincula Arch Handle (Electrosurgery) · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888937015164), received between Sep 3, 2024 and Nov 22, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20756863 ↗InjurySep 16, 2024Device Slipped; Device Slipped
MalfunctionSep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20134654 ↗MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127524 ↗
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
- 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
- USA Series G27L-30WAGyrus ACMI, LLC · Culdoscope (And Accessories)3 reports
- Arch Koh-Efficient KC-ARCH-30Coopersurgical, Inc. · Culdoscope (And Accessories)3 reports
- Arch Koh-Efficient KC-ARCH-40Coopersurgical, Inc. · Culdoscope (And Accessories)2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.