DIRECT DRIVE REPOSABLE GRASPERS

Description of Event or Problem

PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: ATRAX GRASPER WAS BEING USED FOR HYSTERECTOMY PROCEDURE. DURING THE CASE ONE OF THE BLUE PADS ON THE ATRAX GRASPER FELL OFF INSIDE THE PATIENT. THE NURSING STAFF THEN OPENED ANOTHER ATRAX GRASPER C4120 CARTRIDGE AND NOT LONG AFTER A PAD OF THE REPLACEMENT GRASPER ALSO FELL OFF. THE NURSING STAFF MENTIONED THEY WERE UNSURE IF THE PAD WAS LEFT IN THE PATIENT. MORE INFORMATION MAY NEED TO BE REQUESTED FROM THE SURGEON. 19.12.25 [NAME]: UPDATED THE EVENT DATE AND DATE OF AWARENESS BASED ON THE COMPLAINT SHEET ATTACHMENT. 08.01.2026 ADDITIONAL INFORMATION RECEIVED FROM [NAME] (TERRITORY MANAGER) VIA EMAIL: HERE ARE THE RESPONSES TO YOUR QUESTIONS FROM THE DEPARTMENT. ¿ DID A PATIENT ILLNESS OR INJURY OCCUR WITH THE COMPLAINT EVENT? NO. ¿ PATIENT STATUS? I CAN ASSUME WAS DISCHARGED FROM HOSPITAL. ¿ WAS THERE ANY CLINICAL IMPACT TO THE PATIENT? NOT THAT I AM AWARE OF. ¿ THE DESCRIPTION SAYS THEY HAVE DISPOSED OF THE USED SAMPLES, HOWEVER WILL THEY BE RETURNING THE REST OF THE UNUSED BOX THEY HAD ON THE SHELF THAT WAS MENTIONED? THEY WERE THE LAST IN THAT BOX, WE DO HAVE ANOTHER FULL BOX OF THE SAME BATCH NUMBER THAT HAS BEEN REMOVED OFF THE SHELF THAT I WILL TAKE OVER TO (B)(6). PER DISCUSSIONS WITH [NAME], CR WILL ARRANGE FOR THE UNUSED BOX TO BE RETURNED FOR EVALUATION UNDER THIS COMPLAINT. REQUESTED CLARIFICATION ON THE EVENT DATE AND NOTIFIED DATE AS THE DATES IN THE PCF DIDN'T ALIGN WITH THE COMPLAINT SHEET. THE INFORMATION ON THE PCF WAS INCORRECT, AND THE MOST RECENT COMMUNICATION HAS THE CORRECT INFORMATION: 13.01.2026 ADDITIONAL INFORMATION RECEIVED FROM [NAME] (TERRITORY MANAGER) VIA EMAIL: THE DATE OF THE EVENT WAS DEFINITELY THE 16TH OF DECEMBER. THE NUM [NAME] VERBALLY NOTIFIED ME WHEN I WAS IN THEATRES ON THE 17TH WITH [NAME] HOWEVER DIDN¿T HAVE TOO MUCH INFORMATION ON THE EVENT. I RECEIVED THE ACTUAL COMPLAINT EMAIL ON THE 18TH WITH THE INITIAL INFORMATION FROM THE HOSPITAL INTERVENTION: NURSING STAFF REMOVED BOX OF ATRAX OFF SHELF FOR REPLACEMENT PATIENT STATUS: PATIENT INJURY NOT INDICATED.

Additional Manufacturer Narrative

THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO TRENDS WERE IDENTIFIED. CORRECTION: CORRECTING RESPONSE TO E2.

Additional Manufacturer Narrative

THE EVENT UNIT IS NOT BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: ATRAX GRASPER WAS BEING USED FOR HYSTERECTOMY PROCEDURE. DURING THE CASE ONE OF THE BLUE PADS ON THE ATRAX GRASPER FELL OFF INSIDE THE PATIENT. THE NURSING STAFF THEN OPENED ANOTHER ATRAX GRASPER C4120 CARTRIDGE AND NOT LONG AFTER A PAD OF THE REPLACEMENT GRASPER ALSO FELL OFF. THE NURSING STAFF MENTIONED THEY WERE UNSURE IF THE PAD WAS LEFT IN THE PATIENT. MORE INFORMATION MAY NEED TO BE REQUESTED FROM THE SURGEON. ON (B)(6) 2025 [NAME]: UPDATED THE EVENT DATE AND DATE OF AWARENESS BASED ON THE COMPLAINT. 08.01.2026 ADDITIONAL INFORMATION RECEIVED FROM [NAME] (TERRITORY MANAGER) VIA EMAIL: HERE ARE THE RESPONSES TO YOUR QUESTIONS FROM THE DEPARTMENT. DID A PATIENT ILLNESS OR INJURY OCCUR WITH THE COMPLAINT EVENT? NO. PATIENT STATUS? I CAN ASSUME WAS DISCHARGED FROM HOSPITAL. WAS THERE ANY CLINICAL IMPACT TO THE PATIENT? NOT THAT I AM AWARE OF. THE DESCRIPTION SAYS THEY HAVE DISPOSED OF THE USED SAMPLES; HOWEVER, WILL THEY BE RETURNING THE REST OF THE UNUSED BOX THEY HAD ON THE SHELF THAT WAS MENTIONED? THEY WERE THE LAST IN THAT BOX, WE DO HAVE ANOTHER FULL BOX OF THE SAME BATCH NUMBER THAT HAS BEEN REMOVED OFF THE SHELF THAT I WILL TAKE OVER TO (B)(6). PER DISCUSSIONS WITH [NAME], (B)(6) WILL ARRANGE FOR THE UNUSED BOX TO BE RETURNED FOR EVALUATION UNDER THIS COMPLAINT. REQUESTED CLARIFICATION ON THE EVENT DATE AND NOTIFIED DATE AS THE DATES IN THE PCF DIDN'T ALIGN WITH THE COMPLAINT SHEET. THE INFORMATION ON THE PCF WAS INCORRECT, AND THE MOST RECENT COMMUNICATION HAS THE CORRECT INFORMATION: 13.01.2026 ADDITIONAL INFORMATION RECEIVED FROM [NAME] (TERRITORY MANAGER) VIA EMAIL: THE DATE OF THE EVENT WAS DEFINITELY THE 16TH OF DECEMBER. THE NUM [NAME] VERBALLY NOTIFIED ME WHEN I WAS IN THEATRES ON THE 17TH WITH [NAME] HOWEVER, DIDN'T HAVE TOO MUCH INFORMATION ON THE EVENT. I RECEIVED THE ACTUAL COMPLAINT EMAIL ON THE 18TH WITH THE INITIAL INFORMATION FROM THE HOSPITAL INTERVENTION: NURSING STAFF REMOVED BOX OF ATRAX OFF SHELF FOR REPLACEMENT. PATIENT STATUS: PATIENT INJURY NOT INDICATED.