The Recall Desk
HighFDA (Devices)·Z-0440-2013·Announced 2012-12-05

Cooper Surgical Recalls Advincula Arch Uterine Manipulator Handles

Cooper Surgical is recalling Advincula Arch handles because the internal steel rod may protrude through the shaft, posing a risk of injury during surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a mechanical defect could cause injury, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Cooper Surgical, Inc. is recalling 1,215 units of the Advincula Arch, a reusable uterine manipulator handle (Ref: UMH750). The device is intended for use in operative endoscopy (laparoscopy) to position the uterus, fallopian tubes, and ovaries during procedures such as laparoscopic tubal ligation.

The recall is due to a defect where excessive pressure exerted on the uterine tip may cause the internal steel rod to protrude through the cleaning hole on the shaft of the handle. This condition could occur under certain circumstances during use.

The affected units were distributed worldwide, including the United States, Australia, Belgium, Canada, the Czech Republic, Germany, Italy, Spain, France, the United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan. Affected units are identified by a serial number less than 1204001, or between 11110010 and 11110069. Users should stop using the device and contact the manufacturer for instructions.

The recalled product

Product
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types
Manufacturer
Cooper Surgical, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
1,215

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Arch handles with a serial number less than 1204001
  • or between 1111001 0 and 1111 0069

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Cooper Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Cooper Surgical, Inc.

See all →

Same hazard · sharp object protrusion

See all →