Arch Koh-Efficient KC-ARCH-40Recalls & reported problems

Coopersurgical, Inc. · Arch Koh-Efficient - 4.0 cm-Large - for use with Advincula Arch Handle (Electrosurgery) · Class 2

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 00888937015171), received between Sep 11, 2020 and Oct 9, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Device problems

Break1
Material Separation1

Patient problems

Insufficient Information1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 9, 2020Break
WHEN THE UTERINE MANIPULATOR WAS REMOVED BY THE SURGEON IT WAS NOTED TO BE APART. THE BLUE PLASTIC END WAS NO LONGER ATTACHED. ALL PIECES FOUND AND REMOVED FROM THE PATIENT. ARCH KOH-EFFICIENT 4.0 BROKE INTRAOPERATIVELY. KOH-EFFICIENT ARCH 4-0CM KC-ARCH-40 E-(B)(4).
Patient problems: Insufficient Information
MAUDE report 10655695 ↗
MalfunctionSep 11, 2020Material Separation
REPORT SUBMITTED BY CSI REP. INCIDENT REPORT: BLUE COLPOTOMY PART OF KOH CUP SEPARATED DURING ROBOTIC TOTAL HYSTERECTOMY AND WAS LEFT REMAINING INSIDE OF PATIENT. COLPOTOMY CUP WAS RECOVERED BEFORE CASE ENDED, AND ENTIRE LOT HAS BEEN SEQUESTERED. KC-ARCH-40 WAS OPENED FOR DEMONSTRATION OF EVENT AND ALSO SEPARATED FROM THE CUP. (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10523698 ↗

Device details

UDI-DI	`00888937015171`
Brand	Arch Koh-Efficient
Model	KC-ARCH-40
Company	Coopersurgical, Inc.
Product code	HEW · Culdoscope (And Accessories)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 28, 2024

Device type (GMDN): Colpotomy tube

A sterile, hand-held, hollow cylindrical device designed to facilitate dissection of the cervical/vaginal junction during total laparoscopic-assisted hysterectomy. It is typically made of plastic material and functions as a transvaginal conduit for surgical instruments and as an anvil-like support during dissection. Its distal end is designed to fit tightly against the cervix, and its proximal end has a seal to prevent loss of peritoneum-distention gas [e.g., carbon dioxide (CO2)] used during the laparoscopic procedure. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.