DISPOSABLE GRASPING FORCEPS

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. UPON INSPECTION TESTING OF THE RETURNED DEVICE, THE USER'S REQUEST WAS CONFIRMED. IT WAS DISCOVERED, THE GRASPING PORTION COULD NOT BE OPENED BECAUSE THE TUBE WAS COMPRESSIVELY BUCKLED. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS ISSUE AND ANY REQUIRED MDR REPORTING. THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. THE FOLLOWING MEDWATCH REPORTS ARE RELATED: PATIENT IDENTIFIERS (B)(6) IS FOR LOT 13K, THIS COMPLAINT. (B)(6) IS FOR LOT 84K. (B)(6) IS FOR LOT 16K.

Description of Event or Problem

AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE USER, PRIOR TO AN UNKNOWN PROCEDURE, THREE DISPOSABLE GRASPING FORCEPS COULD NOT BE OPENED AND/OR CLOSED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. IT WAS FURTHER REPORTED, THIS TYPE OF PROCEDURE TAKES 14 MINUTES, HOWEVER; THE START OF THIS PROCEDURE WAS DELAYED BY 30 MINUTES DUE TO THIS EVENT. THERE WERE NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. WITH REGARD TO THE DEVICE MANUFACTURE DATE, ONLY THE MONTH AND MONTH AND YEAR ARE KNOWN: FEBRUARY, 2021. FURTHERMORE, THE CORRECT LOT NUMBER FOR THE DEVICE IS 12K AND NOT 13K.

Additional Manufacturer Narrative

CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 28-FEB-2022. UPDATED FIELDS: D8, H6 AND H10. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE FOR THIS ISSUE WAS NOT ESTABLISHED. HOWEVER, IT IS PROBABLE THAT THE ISSUE OCCURRED BECAUSE THE TUBE WAS BENT AT AN ACUTE ANGLE WITH AN EXCESSIVE FORCE DURING HANDLING. THIS BENDING CAUSED IT TO BUCKLE, AND IT WAS THOUGHT THAT THIS BUCKLING INCREASED THE SLIDING RESISTANCE BETWEEN THE TUBE AND THE OPERATION WIRE. HENCE THE DIFFICULTY IN OPENING/CLOSING THE BASKET THAT WAS REPORTED BY THE USER. THE OCCURRENCE OF THE REPORTED PROBLEM CAN BE PREVENTED BY ADHERING TO THE INSTRUCTIONS FOR USE (IFU), WHICH STATE THE FOLLOWING: ¿·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 PORTION. THIS COULD DAMAGE THE INSTRUMENT. ·WHEN THE GRASPING PORTION DOES NOT OPEN AND/OR CLOSE SMOOTHLY, DO NOT APPLY FORCE BUT SET THE SCOPE¿S ANGLE BACK, OR MOVE THE POSITION OF THE GRASPING PORTION UNTIL THE BASKET OPENS AND CLOSES SMOOTHLY. IF THE ACTION IS FORCED, THE TUBE MAY STRETCH AND THE RESISTANCE OF THE HANDLE MAY INCREASE. ALSO THE CALCULUS MAY NOT BE RETRIEVED, AND/OR THE GRASPING PORTION WITH CALCULUS ENGAGED MAY NOT BE REMOVED FROM THE BODY.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS ISSUE AND ANY REQUIRED MDR REPORTING.