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Recall Observatory FDA recall evidence

Device product

Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).

Z-1977-2019

June 14, 2019

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 83105
Status
Terminated
Classification
Class II
Quantity
213 units in total
Official record key
device-enforcement:Z-1977-2019

Official wording

Reason: The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.

Code information: Lot 017-19

Distribution pattern: US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.