FDA
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.
In July 2017, Dannoritzer Medizintechnik GmbH & Co. KG issued emails to customers notifying them that an updated Instructions For Use (IFU) manual would be distributed by July 27, 2018. On August 8, 2018, Dannoritzer Medizintechnik GmbH & Co. KG issued Urgent Medical Device Field Correction notices dated August 6, 2018 to customers along with an updated IFU.
Customers were encouraged to immediately remove from their place of use and destroy the existing original DANmed Laparoscopy Instruments IFU as well as any copies and replace them with the revised version (V.2018-08-03) included with the notice.
Distributors or those who have further distributed the product, please provide those customers with a copy of the notice and revised IFU.
Customers are also encouraged to complete and return the Confirmation Card and email to notification@danrepair.de
Customers with questions may contact Stefan Rauch 011-49-7461-9623915 8 am - 12 PM, EST or email notification@danrepair.de