Important Safety Alerts

Medical device manufacturer, Applied Medical, has issued a medical device safety alert concerning its Laparoscopic Grasper. The affected products are identified as follow:

• Epix Laparoscopic Grasper 5mm x 35cm [Model C4130; Lot Number: 1364578, 1366453, 1371249, 1373050, 1373248, 1373249, 1373255, 1373260, 1373261, 1373262, 1373263, 1377363, 1377364]
• Epix Laparoscopic Grasper 5mm x 45cm [Model C4140; Lot Number: 1366454, 1371261, 1371262, 1373051, 1373256, 1376369]
• Laparoscopic Cholecystectomy Kit [Model K0880; Lot Number: 1378830, 1379253, 1380094, 1381695]
• Clip Applier Kit [Model K2887; Lot Number: 1380797, 1382197]

The manufacturer is conducting a voluntary recall of specific lot numbers of the Epix Laparoscopic Grasper due to the potential for tissue to catch on a slightly protruding rivet on the distal end of the device, which may lead to tissue damage. The manufacturer has not received any reports of impairment or permanent injury related to tissue catching.

All affected lots for models C4130 and C4140 of the Epix Laparoscopic Graspers, Kits, and Procedural Packs containing these models, K0880 and K2887, should be returned to the manufacturer. Product recall is on-going.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 23 March 2020