HUMI 6001Recalls & reported problems

Coopersurgical, Inc. · HUMI® Harris-Kronner Uterine Manipulator-Injector O.D.: 5 mm • Length: 33 cm (13") • Recommended Balloon Inflation: Air 10 cc · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937013238), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 malfunction.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 23, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21891561 ↗

Device details

UDI-DI	`00888937013238`
Brand	HUMI
Model	6001
Company	Coopersurgical, Inc.
Product code	KNA · Instrument, Manual, Specialized Obstetric-Gynecologic
Class	Class 2
FDA submission	K770727
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): Uterine manipulator, single-use

A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.

Other Instrument, Manual, Specialized Obstetric-Gynecologic devices

Centurion HUD56ST
Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
1 recall0 reports
Centurion HUD112ST
Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
1 recall0 reports
Centurion HUD12ST
Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
1 recall0 reports
Centurion HUD910ST
Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
1 recall0 reports
Alexis ® O C-Section Protector - Retractor G6313
Applied Medical Resources Corporation · Instrument, Manual, Specialized Obstetric-Gynecologic
14 reports
AESCULAP PL430R
Aesculap AG · INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
3 reports
Cook G17080
Cook Incorporated · INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
2 reports
Alexis ® O C-Section Protector - Retractor G6314
Applied Medical Resources Corporation · Instrument, Manual, Specialized Obstetric-Gynecologic
2 reports

All Instrument, Manual, Specialized Obstetric-Gynecologic devices →

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