Recall Z-1978-2019 ยท HEW Culdoscope (And Accessories)
CooperSurgical, Inc.
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 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).
| Date | Jun 14, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On June 14, 2019, the firm, CooperSurgical, notified customers of the recall via "URGENT: MEDICAL DEVICE RECALL" letters. Customers were informed that the soft, flexible cup of the Advincula Delineator may crack when subjected to excessive compression during use. The failure mode could lead to serious health consequences such as lacerations. Customers are asked to do the following; - Quarantine affected products - Complete the enclosed Acknowledgement and Receipt form and return to Cooper Surgical via email: recall@coopersurgical.com or fax to 203.601.9870 ATTN: Product Surveillance, even i |
| Quantity | 213 units in total |
| Distribution | US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180429 | Advincula Delineator Uterine Manipulator CooperSurgical, Inc., Mar 14, 2018 |