GRASPING FORCEPS

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS NOT YET RECEIVED FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. AS A PREVENTIVE MEASURE AND PER THE USER MANUAL UNDER WARNINGS : BEFORE USE, CONFIRM THAT THE INSTRUMENT IS NOT CORRODED, DENTED OR DISCOLORED, DO NOT USE IT IF ANY OF THESE CONDITIONS ARE OBSERVED. IF THE INSTRUMENT IS DAMAGED, PART OF IT COULD FALL OFF INSIDE THE PATIENT, OR IT COULD BECOME IMPOSSIBLE TO OPEN OR CLOSE. IF THE INSTRUMENT DOES NOT OPERATE PROPERLY DURING THE PROCEDURE, OR IF IT BECOMES DIFFICULT TO OPEN OR CLOSE THE GRASPING JAWS, STOP THE PROCEDURE IMMEDIATELY AND WITHDRAW THE INSTRUMENT INTO THE ENDOSCOPE¿S CHANNEL. IF THIS IS NOT POSSIBLE, CAREFULLY REMOVE IT TOGETHER WITH THE ENDOSCOPE TO AVOID CAUSING PATIENT INJURY. IF A PART OF THE INSTRUMENT FALLS OFF INSIDE THE PATIENT, USE A SPARE INSTRUMENT TO RETRIEVE IT. DO NOT COIL THE INSERTION PORTION WITH A DIAMETER OF LESS THAN 15 CM. THIS COULD DAMAGE THE INSERTION PORTION. NEVER USE EXCESSIVE FORCE TO OPEN OR CLOSE THE GRASPING JAWS. THIS COULD DAMAGE THE INSTRUMENT.

Description of Event or Problem

DURING AN ENDOSCOPY PROCEDURE FOR THE REMOVAL OF A FOREIGN OBJECT (PIECES OF CHICKEN), IT WAS REPORTED THAT THE FORCEPS BROKE INSIDE THE ESOPHAGEAL MUCOSA OF THE PATIENT. ADDITIONALLY, IT WAS REPORTED THAT THE LOOSE PART OF THE FORCEPS WERE RECOVERED .THERE WAS NO PATIENT INJURY REPORTED.

Description of Event or Problem

ISSUE OCCURRED IN THE BEGINNING OF THE PROCEDURE. DEVICE WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE OBSERVED. LOOSE PART OF THE FORCEPS (GRASPING JAWS) WERE RETRIEVED USING ANOTHER FORCEPS. NO BLEEDING OBSERVED. PROCEDURE WAS COMPLETED USING A GASTROSCOPE. PATIENT IS FINE AND NO FOLLOW UP CHECK IS REQUIRED.