Description of Event or Problem · 0
A HEALTHCARE PROFESSIONAL REPORTED AN ISSUE REGARDING 2 DEVICES OF FLEX. GRASP. FORCEPS 5FR WL 550MM, PART NO. 828.051, BATCH # 4500359201. THE USER FACILITY STATED ON THE 1ST DEVICE, "WHEN OPENING AND CLOSING THE GRASPER IT FEELS LIKE THERE IS A PINCH IN THE SHAFT OF THE GRASPER AND IT IS VISIBLE WHEN LOOK AT THE TIPS OPEN AND CLOSE." RWMIC ASSIGNED COMPLAINT (B)(4) (A) ON 1ST DEVICE. THIS WAS REPORTED UNDER IMPORTER MDR 1418479-2023-00006 AND MANUFACTURER MDR 9611102-2023-00015. A 2ND DEVICE WAS RETURNED TOGETHER WITH THE 1ST DEVICE. RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) ASSIGNED COMPLAINT (B)(4) (B). THE USER FACILITY SHIPPED BACK THIS DEVICE SINCE, BOTH DEVICES HAVE SIMILAR PRODUCT ID: 858.051 AND BELONGS TO THE SAME BATCH # 4500359201. ONLY THE 1ST DEVICE WAS INVOLVED IN THE REPORTED INCIDENT. ON (B)(6) 2023, A PRELIMINARY DEVICE EVALUATION WAS PERFORMED WITH THE 2ND DEVICE (B)(4) AT RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC). ACCORDING TO THE RESPONSIBLE SERVICE DEPARTMENT, THE REPORTED CONDITION WAS CONFIRMED THAT THE JAWS DO NOT CLOSE CONSISTENTLY. HOWEVER, PHYSICAL CAUSE OF THE ISSUE COULD NOT BE DETERMINED. RWMIC DECIDED TO REPORT AS THE 2ND DEVICE EXHIBITS A SIMILAR ISSUE. ALSO, THERE WAS NOTIFICATION #: 9611102-03-22-2023-001-C ASSIGNED ON THIS MATTER. THE DEVICE WAS SENT TO THE MANUFACTURER (RICHARD WOLF GMBH) FOR FURTHER INVESTIGATION.