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Patient 1
PENTAX MEDICAL RECEIVED BIOPSY FORCEPS WITH WINDOWS AND SPIKE MODEL #KH-2422S/ SERIAL # (B)(4) AND A VISUAL INSPECTION WAS PERFORMED ON 06/03/2015. THE VISUAL INSPECTION CONFIRMED BREAKAGE BY THE HANDLE AREA. NO OTHER VISUAL DEFECTS WERE NOTED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO THE INITIAL REPORTER ON 06/03/2015 AND 06/11/2015 TO CONFIRM DETAILS OF THE EVENT FOR THE INVESTIGATION AND IN ORDER TO BE ABLE TO ASSESS THE EVENT FOR REPORTABILITY. A PHONE CONVERSATION WAS HELD WITH THE INITIAL REPORTER ON (B)(4) 2015 WHO CONFIRMED THAT THE BREAKAGE OCCURRED DURING PROCEDURE AND NO INJURIES TO THE PT OR USER OCCURRED. DUE TO THESE ADDITIONAL DETAILS, THE EVENT WAS DETERMINED TO BE A REPORTABLE EVENT ON (B)(4) 2015. NO OTHER DETAILS SURROUNDING THE EVENT WERE RECEIVED FROM THE INITIAL REPORTER. BASED ON THE INFO RECEIVED FROM THE INITIAL REPORTER AND THE VISUAL INSPECTION PERFORMED BY PENTAX MEDICAL, A ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. THE ONLY POSSIBILITIES ARE TO SUGGEST THE USER APPLIED EXCESSIVE FORCE WHICH RESULTED IN THE BREAKAGE OR THE BREAKAGE WAS A RESULT OF A MFG NON-CONFORMITY. SINCE THE ROOT CAUSE FOR THIS COMPLAINT IS UNK, A CORRECTIVE ACTION REQUEST WAS INITIATED FOR THE MFR, ALONG WITH SENDING THE SAMPLE INVOLVED IN THIS EVENT, TO FURTHER EVALUATE THE PRODUCT AND IMPLEMENT ANY CORRECTIVE ACTIONS, IF NECESSARY. PENTAX MEDICAL HAS NOT RECEIVED ANY OTHER INFO REGARDING THIS EVENT OR THE MEDICAL DEVICE INVOLVED, AND THEREFORE CONSIDERS THIS MEDWATCH REPORT CLOSED.