BEUDAMED
    FDA Recall Open, Classified

    FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685

    Recall: Z-1425-2023 · Initiated March 24, 2023

    Recall

    Recall Number
    Z-1425-2023
    Event Number
    91953
    Firm
    Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany
    FEI Number
    3002808001
    Product Code
    FCL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 24, 2023
    Posted
    April 24, 2023

    Description

    FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685

    Reason

    Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.

    Action

    The firm issued an Urgent Medical Device Correction notice on 03/24/2023 to its consignees by USPS certified mail. The notice explained the issue and explained the proper use of the device to avoid exposing patients to improper handling. Richard Wolf is already optimizing the forceps design. Further batches of these forceps can be used with the expected maximum flexibility. The procedure described in the notice does not expose patients to risks from jaw sections that do not open. The firm issued a follow up letter titled, Urgent Medical Device Removal beginning on 08/02/2023, via USPS certified mail. The notice advised customers that the device has been redesigned. Customers were instructed to review inventory, ensure all users are informed of the recall, notify customers if further distributed, return the customer response form, arrange for the shipment of revised forceps and return affected devices. The firm issued an updated letter to customers who have not yet responded to the original notification on about 09/12/2023. The updated letter included an image of where to locate the lot/batch number on the forceps, and the table of lot/batch numbers was also reorganized for better readability.

    Distribution

    Worldwide distribution - US Nationwide and the countries of United Arab Emirates (AE), Argentina (AR), Austria (AT), Belgium (BE), BO, Brazil (BR), Canada (CA), Chile (CL), Czech Republic (CZ), Germany (DE), Denmark (DK), Ecuador (EC), Spain (ES), Finland (FI), France (FR), Greece (GR), Hong Kong (HK), Croatia (HR), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), South Korea (KR), Kuwait (KW), Kazakhstan (KZ), LB, Lithuania (LT), Marzocco (MA), Mexico (MX), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Pakistan (PK), Poland (PL), Palestine (PS), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudi Arabia (SA), Slovenia (SI), Slovakia (SK), Thailand (TH), Turkey (TR).

    Quantity

    280 units