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Recall Observatory FDA recall evidence

Device 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 of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

Z-0440-2013

October 31, 2012

Class II

Product summary

Firm
Cooper Surgical, Inc.
Event
Event 63681
Status
Terminated
Classification
Class II
Quantity
1215 total
Official record key
device-enforcement:Z-0440-2013

Official wording

Reason: Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle

Code information: Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle