Recall Z-0643-2018 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Pentax of America Inc
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic
| Date | Feb 20, 2018 (initiated Feb 13, 2018) |
| Status | Terminated |
| Reason | The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy. |
| Root cause | Device Design |
| Action | Pentax Medical sent an Urgent Medical Device Correction/Removal letter dated February 7, 2018, to the United States Customers. The consignee letter includes a customer response form and a revised operator manual with the added recommended periodic maintenance. The letter requests the return of the form which includes an accounting of the devices (by serial number) owned by the facility. The firm is to contact the consignee to arrange return of the affected units and to provide loaner devices as needed. For further questions, please call 1 (800) 431-5880 ext. 2064. |
| Quantity | 559 |
| Distribution | USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District of Columbia. |
| FDA record | Open on fda.gov |