DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

Each domestic consignee was notified by Urgent: Medical Device Recall letter, dated March 16, 2020 sent to distributors 3/19/2020 via email and domestic consignees on March 19, 2020 via UPS. It notified customers of recall of specific lots due to the potential for tissue to catch on a slightly protruding riven on the distal end of the device, which may lead to tissue damage. It instructed customers to complete the following actions: 1) Check inventory for recalled product. 2) Complete the attached Customer Recall Notification Confirmation Form (Page 3) to acknowledge the Recall. Please then indicate if your facility is returning or has already used devices from this lot. Please note that you must return the form even if you have no devices in inventory. 3) If a distributor, please notify any facilities to which they distributed the affected product. Please also complete the Distributor Recall Notification Confirmation Form (Page 4). 4) Return the Customer Recall Notification Confirmation Form to Applied Medical by email at [email protected] or fax to (949) 688-2125. 5) Return affected product and a copy of the Customer Recall Notification Confirmation Form to Applied Medical.Product Return Instructions are on Page 5. NOTE: If a distributor, please notify any facilities to which they distributed the affected product. Also,please contact your local regulatory agency. It listed the following contact information for additional questions and/or MDR reporting: For product return questions, please contact Jaclene Rios-Simpson, RGA Dept. at (949) 713-8688 or by email [email protected]. For regulatory questions, please contact Lauren Contursi at (949) 713-8767 or by email at [email protected]. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.