Arch Koh-Efficient KC-ARCH-30Recalls & reported problems
Coopersurgical, Inc. · Arch Koh-Efficient - 3.0 cm small- for use with Advincula Arch Handle (Electrosurgery) · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888937015157), received between Sep 11, 2020 and Jun 2, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 Component2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY, THE BLUE RING ON KOH-EFFICIENT DEVICE CAME APART FROM WHITE BODY OF ITEM WHEN ATTEMPTING TO REMOVE PATIENT'S UTERUS THROUGH VAGINA. BLUE RING INSIDE PATIENT'S PELVIS WHEN IT CAME APART AND WAS REMOVED BY THE DOCTOR. NO PATIENT HARM. NO ADDITIONAL INFORMATION AVAILABLE. KC-ARCH-30 KOH-EFFICIENT 2025-05-0000066.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22123644 ↗MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE DEVICE BECAME UNABLE TO MANIPULATE BEFORE THE COLPOTOMY. THE SURGEON SCRUBBED BACK IN TO HELP OUT AND SEE IF SHE COULD MAYBE REPOSITION THE MANIPULATOR. WHEN SHE PULLED THE MANIPULATOR OUT TO REPOSITION, THE BLUE CUP WAS NOT ON THE KOH EFFICIENT. SHE LOOKED IN AND SAW IT WAS STILL INSIDE THE VAGINA. SHE REMOVED IT WITHOUT DIFFICULTY AND REINSERTED ANOTHER MANIPULATOR. THEY DID NOT HAVE ANY TROUBLE WITH THAT MANIPULATOR DOING THE COLPOTOMY AND PULLING THE UTERUS OUT. NO PATIENT HARM. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21066638 ↗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. (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 10520763 ↗
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
- Arch Koh-Efficient KC-ARCH-35Coopersurgical, Inc. · 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-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.