The Recall Desk
SevereFDA (Devices)·Z-0439-2013·Announced 2012-12-05

Cooper Surgical RUMI Arch Uterine Manipulator Handle Recalled for Steel Rod Protrusion

Cooper Surgical is recalling RUMI Arch handles because excessive pressure may cause an internal steel rod to protrude through the shaft.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could cause injury during surgery, meeting the criteria for a Severe rating.

Plain-English summary

Cooper Surgical, Inc. is recalling the RUMI Arch, Reusable Uterine Manipulator Handle (Ref: UMH700). The recall involves 1,215 units distributed worldwide, including the United States and various international markets. The product is intended for use in operative endoscopy (laparoscopy) to position the uterus, fallopian tubes, and ovaries.

The recall is being issued because excessive pressure exerted on the uterine tip when attached to the Arch may cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle under certain circumstances. This defect presents a risk of injury to patients or medical personnel during surgical procedures.

The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare facilities and distributors should stop using the affected devices and contact Cooper Surgical for instructions on return or replacement.

The recalled product

Product
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 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 of surg
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 (1)

  • All serial numbers

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 →