BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C0H11, KII DISSECTING BALLOON, OVL, 3/BX

    MDR report key: 13876408 · Received March 24, 2022

    Report

    Report Number
    2027111-2022-00507
    Event Type
    Injury
    Date Received
    March 24, 2022
    Report Date
    June 28, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K182024
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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 DAMAGES OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. AT THIS TIME, APPLIED MEDICAL IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE INJURY OR CONFIRM THAT A PRODUCT MALFUNCTION OCCURRED. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: INGUINAL HERNIA REPAIR. EVENT DESCRIPTION: BASED ON THE INFORMATION PROVIDED, IT IS ESTIMATED THAT 35 COMPLAINT EVENTS OCCURRED AT THIS FACILITY INVOLVING PERITONEAL INJURIES. THIRTY-FIVE COMPLAINTS HAVE BEEN CREATED TO DOCUMENT EVENTS AT [] HOSPITAL INVOLVING PERITONEAL INJURIES THAT WERE NOTED WHILE USING THE C0H11 PRODUCT. 01: 2021-000237 (REPORT # 2027111-2021-00327); 02: 2021-003017 (REPORT # 2027111-2022-00300); 03: 2022-000033 (REPORT # 2027111-2022-00317); 04: 2022-000366 (REPORT # 2027111-2022-00364); 05: 2022-000434 (REPORT # 2027111-2022-00402); 06: 2022-000329; 07: 2022-000792; 08: 2022-000797; 09: 2022-000798; 10: 2022-000799; 11: 2022-000800; 12: 2022-000801; 13: 2022-000802; 14: 2022-000803; 15: 2022-000804; 16: 2022-000805; 17: 2022-000806; 18: 2022-000807; 19: 2022-000808; 20: 2022-000809; 21: 2022-000810; 22: 2022-000811; 23: 2022-000826; 24: 2022-000827; 25: 2022-000828; 26: 2022-000829; 27: 2022-000836; 28: 2022-000837; 29: 2022-000838; 30: 2022-000839; 31: 2022-000840; 32: 2022-000841; 33: 2022-000842; 34: 2022-000843; 35: 2022-000844. APPLIED MEDICAL REPRESENTATIVES HAD A MEETING WITH THE REP FOR [] HOSPITAL ON (B)(6) 2022 REGARDING THE RECENT SERIES OF DISSECTING BALLOON COMPLAINTS THAT HAVE OCCURRED AT THIS FACILITY. DURING THIS MEETING THE REP NOTED THAT WHILE THEY WERE ONLY ABLE TO CONFIRM 5 EVENTS SO FAR, THE SURGEON PREVIOUSLY CLAIMED THAT THEY ENCOUNTERED ISSUES WITH THE DEVICE ON ABOUT 25% OF THE CASES THEY USED THE DEVICE FOR. THE REP ESTIMATES THE SURGEON PERFORMS ABOUT 5-8 TEP PROCEDURES PER WEEK. THE FACILITY FIRST STARTED USING THE PRODUCT IN DECEMBER OF 2020. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15FEB2022 FROM APPLIED MEDICAL REPRESENTATIVE: "I HAVE NOT BEEN MADE AWARE OF ANY PATIENT INJURY." "THE PRODUCTS THAT WERE NOT AVAILABLE FOR RETURN HAVE BEEN DISPOSED OF BY THE FACILITY." "THE ONLY DEVICE I HAVE RECEIVED COMPLAINTS ABOUT IS C0H11 THE OVAL BALLOON." ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 16FEB2022 FROM APPLIED MEDICAL REPRESENTATIVE: THE REP SPOKE TO THE SURGEON ABOUT THE EVENT RATE. THE SURGEON CONFIRMED THAT THEY ENCOUNTERED ISSUES USING THE DEVICE ON ABOUT 25% OF THEIR PROCEDURES. THE FACILITY ALSO INFORMED THE REP THAT A SECOND SURGEON AT THE SAME FACILITY WAS EXPERIENCING SIMILAR ISSUES UNTIL THEY STOPPED USING THE TEP APPROACH FOR THEIR PROCEDURES. AT THIS TIME THE REP HAS NOT BEEN PROVIDED ANY FURTHER INFORMATION, INCLUDING INFORMATION REGARDING THE NUMBER OF EVENTS OR THE OCCURRENCE OF ANY PATIENT INJURY. THE REP WILL BE FOLLOWING UP TO TRY TO GATHER THIS INFORMATION. ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 17FEB2022 FROM APPLIED MEDICAL REPRESENTATIVE: THE REP SPOKE TO A THIRD SURGEON AT THIS FACILITY. THIS SURGEON CLAIMS THEY HAVE BEEN ENCOUNTERING ISSUES WITH POSTERIOR SHEATH PERITONEUM DEFECTS. THE SURGEON STATES THIS HAS OCCURRED ON ABOUT 20% OF INGUINAL HERNIA REPAIR CASES WHICH USED THE TEP APPROACH. THE REP IS CURRENTLY ATTEMPTING TO CONFIRM THE CASE NUMBERS FOR ALL OF THE SURGEONS WHO ARE REPORTING THIS ISSUE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23FEB2022 FROM APPLIED MEDICAL REPRESENTATIVE: "THE 3RD SURGEON THAT HAD DIFFICULTY WITH OUR DISSECTING BALLOON C0H11 EXPLAINED THAT IT CAUSED PERITONEUM DEFECTS IN 25% OF HIS CASES. THE FIRST SURGEON EXPRESSED 25% AND THE SECOND SURGEON STATED 20%." ADDITIONAL INFORMATION RECEIVED FROM SURGEONS VIA FEEDBACK FORM RECEIVED FROM CLINICAL DEVELOPMENT FROM 2MAR2022 ¿ 4MAR2022: DR. [A]: THE PHYSICIAN FEELS THAT IT IS MORE LIKELY TO POKE THROUGH PERITONEUM UPON INSERTION WITH OUR DEVICE AS COMPARED TO THE DEVICE THEY USED PREVIOUSLY. THEY NOTICED THIS DIFFERENCE IN FREQUENCY RIGHT AS THE HOSPITAL SWITCHED PRODUCT. THEY PREVIOUSLY ESTIMATED 20% OF USES RESULTED IN PERITONEAL DEFECT, BUT EVER SINCE THEY HAVE ADJUSTED THEIR TECHNIQUE, IT HAS BEEN OCCURRING LESS FREQUENTLY. THE PHYSICIAN ONLY DOES LAP TAPP WHEN SWITCHING FROM TEP IN A PROCEDURE. THEY ALSO USE THIS APPROACH WITH HIGH BMI PATIENTS. DR. [B]: THE PHYSICIAN HAD ISSUES WITH TEARING THROUGH PERITONEUM UPON INSERTION. THIS RESULTS IN A NEED TO CONVERT TO TAPP, THEN CLOSE DEFECT WITH TACKERS WHICH CAN BE DIFFICULT BECAUSE OF WEIRD ANGLE. THEY STARTED HAVING ISSUES WITH C0H11 SOON AFTER FIRST RECEIVING THE PRODUCT. THEY ESTIMATE FREQUENCY OF TEARS AT 20%. THE PHYSICIAN REDUCED HIS NUMBER OF TEP CASES AND MOVED THEM TO ROBOTIC TAPP BECAUSE OF ISSUES WITH OUR BALLOON. ONLY DOES TEP FOR SMALL PRIMARY HERNIAS, IF BMI OVER 35-38, THEY PREFER TO DO ROBOTIC TAPP. DR. [C]: THIS SURGEON HAS THE HIGHEST FREQUENCY OF ISSUES. THEY BELIEVE THAT THE C0H11, EITHER DURING INSERTION OR INFLATION, CAUSES TEARING OF THE PERITONEUM. CLAIMS THAT 1 IN 3 USES RESULTS IN PERITONEAL DEFECT. INTERVENTION: SURGEON REPAIRED TEAR/HOLE. PATIENT STATUS: PERITONEAL TEAR/HOLE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: INGUINAL HERNIA REPAIR. EVENT DESCRIPTION: BASED ON THE INFORMATION PROVIDED, IT IS ESTIMATED THAT 35 COMPLAINT EVENTS OCCURRED AT THIS FACILITY INVOLVING PERITONEAL INJURIES. THIRTY-FIVE COMPLAINTS HAVE BEEN CREATED TO DOCUMENT EVENTS AT HOSPITAL INVOLVING PERITONEAL INJURIES THAT WERE NOTED WHILE USING THE C0H11 PRODUCT. 01: 2021-000237 (REPORT # 2027111-2021-00327); 02: 2021-003017 (REPORT # 2027111-2022-00300); 03: 2022-000033 (REPORT # 2027111-2022-00317); 04: 2022-000366 (REPORT # 2027111-2022-00364); 05: 2022-000434 (REPORT # 2027111-2022-00402); 06: 2022-000329 (REPORT# 2027111-2022-00493); 07: 2022-000792 (REPORT# 2027111-2022-00503); 08: 2022-000797 (REPORT# 2027111-2022 -00504); 09: 2022-000798 (REPORT# 2027111 -2022-00505); 10: 2022-000799 (REPORT# 2027111-2022 -00506); 11: 2022-000800 (REPORT# 2027111-2022 -00507); 12: 2022-000801 (REPORT# 2027111-2022 -00508); 13: 2022-000802 (REPORT# 2027111-2022 -00513); 14: 2022-000803 (REPORT# 2027111-2022-00514); 15: 2022-000804 (REPORT# 2027111-2022-00515); 16: 2022-000805 (REPORT# 2027111-2022-00517); 17: 2022-000806 (REPORT# 2027111-2022-00518); 18: 2022-000807 (REPORT# 2027111-2022-00525); 19: 2022-000808 (REPORT# 2027111-2022-00524); 20: 2022-000809 (REPORT# 2027111-2022-00523); 21: 2022-000810 (REPORT# 2027111-2022-00522); 22: 2022-000811 (REPORT# 2027111-2022-00521); 23: 2022-000826 (REPORT# 2027111-2022-00520); 24: 2022-000827 (REPORT# 2027111-2022-00519); 25: 2022-000828 (REPORT# 2027111-2022-00516); 26: 2022-000829 (REPORT# 2027111-2022-00512); 27: 2022-000836 (REPORT# 2027111-2022-00511); 28: 2022-000837 (REPORT# 2027111-2022-00510); 29: 2022-000838 (REPORT# 2027111-2022-00509); 30: 2022-000839 (REPORT# 2027111 -2022-00502); 31: 2022-000840 (REPORT# 2027111-2022-00501); 32: 2022-000841 (REPORT# 2027111-2022-00500); 33: 2022-000842 (REPORT# 2027111-2022-00499); 34: 2022-000843 (REPORT# 2027111-2022-00498); 35: 2022-000844 (REPORT# 2027111-2022-00497). APPLIED MEDICAL REPRESENTATIVES HAD A MEETING WITH THE REP FOR HOSPITAL ON 07FEB2022 REGARDING THE RECENT SERIES OF DISSECTING BALLOON COMPLAINTS THAT HAVE OCCURRED AT THIS FACILITY. DURING THIS MEETING THE REP NOTED THAT WHILE THEY WERE ONLY ABLE TO CONFIRM 5 EVENTS SO FAR, THE SURGEON PREVIOUSLY CLAIMED THAT THEY ENCOUNTERED ISSUES WITH THE DEVICE ON ABOUT 25% OF THE CASES THEY USED THE DEVICE FOR. THE REP ESTIMATES THE SURGEON PERFORMS ABOUT 5-8 TEP PROCEDURES PER WEEK. THE FACILITY FIRST STARTED USING THE PRODUCT IN (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15FEB2022 FROM APPLIED MEDICAL REPRESENTATIVE: "I HAVE NOT BEEN MADE AWARE OF ANY PATIENT INJURY." "THE PRODUCTS THAT WERE NOT AVAILABLE FOR RETURN HAVE BEEN DISPOSED OF BY THE FACILITY." "THE ONLY DEVICE I HAVE RECEIVED COMPLAINTS ABOUT IS C0H11 THE OVAL BALLOON." ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 16FEB2022 FROM APPLIED MEDICAL REPRESENTATIVE: THE REP SPOKE TO THE SURGEON ABOUT THE EVENT RATE. THE SURGEON CONFIRMED THAT THEY ENCOUNTERED ISSUES USING THE DEVICE ON ABOUT 25% OF THEIR PROCEDURES. THE FACILITY ALSO INFORMED THE REP THAT A SECOND SURGEON AT THE SAME FACILITY WAS EXPERIENCING SIMILAR ISSUES UNTIL THEY STOPPED USING THE TEP APPROACH FOR THEIR PROCEDURES. AT THIS TIME THE REP HAS NOT BEEN PROVIDED ANY FURTHER INFORMATION, INCLUDING INFORMATION REGARDING THE NUMBER OF EVENTS OR THE OCCURRENCE OF ANY PATIENT INJURY. THE REP WILL BE FOLLOWING UP TO TRY TO GATHER THIS INFORMATION. ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 17FEB2022 FROM APPLIED MEDICAL REPRESENTATIVE: THE REP SPOKE TO A THIRD SURGEON AT THIS FACILITY. THIS SURGEON CLAIMS THEY HAVE BEEN ENCOUNTERING ISSUES WITH POSTERIOR SHEATH PERITONEUM DEFECTS. THE SURGEON STATES THIS HAS OCCURRED ON ABOUT 20% OF INGUINAL HERNIA REPAIR CASES WHICH USED THE TEP APPROACH. THE REP IS CURRENTLY ATTEMPTING TO CONFIRM THE CASE NUMBERS FOR ALL OF THE SURGEONS WHO ARE REPORTING THIS ISSUE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23FEB2022 FROM APPLIED MEDICAL REPRESENTATIVE: "THE 3RD SURGEON THAT HAD DIFFICULTY WITH OUR DISSECTING BALLOON C0H11 EXPLAINED THAT IT CAUSED PERITONEUM DEFECTS IN 25% OF HIS CASES. THE FIRST SURGEON EXPRESSED 25% AND THE SECOND SURGEON STATED 20%." ADDITIONAL INFORMATION RECEIVED FROM SURGEONS VIA FEEDBACK FORM RECEIVED FROM CLINICAL DEVELOPMENT FROM 2MAR2022 ¿ 4MAR2022: DR. [A]: THE PHYSICIAN FEELS THAT IT IS MORE LIKELY TO POKE THROUGH PERITONEUM UPON INSERTION WITH OUR DEVICE AS COMPARED TO THE DEVICE THEY USED PREVIOUSLY. THEY NOTICED THIS DIFFERENCE IN FREQUENCY RIGHT AS THE HOSPITAL SWITCHED PRODUCT. THEY PREVIOUSLY ESTIMATED 20% OF USES RESULTED IN PERITONEAL DEFECT, BUT EVER SINCE THEY HAVE ADJUSTED THEIR TECHNIQUE, IT HAS BEEN OCCURRING LESS FREQUENTLY. THE PHYSICIAN ONLY DOES LAP TAPP WHEN SWITCHING FROM TEP IN A PROCEDURE. THEY ALSO USE THIS APPROACH WITH HIGH BMI PATIENTS. DR. [B]: THE PHYSICIAN HAD ISSUES WITH TEARING THROUGH PERITONEUM UPON INSERTION. THIS RESULTS IN A NEED TO CONVERT TO TAPP, THEN CLOSE DEFECT WITH TACKERS WHICH CAN BE DIFFICULT BECAUSE OF WEIRD ANGLE. THEY STARTED HAVING ISSUES WITH C0H11 SOON AFTER FIRST RECEIVING THE PRODUCT. THEY ESTIMATE FREQUENCY OF TEARS AT 20%. THE PHYSICIAN REDUCED HIS NUMBER OF TEP CASES AND MOVED THEM TO ROBOTIC TAPP BECAUSE OF ISSUES WITH OUR BALLOON. ONLY DOES TEP FOR SMALL PRIMARY HERNIAS, IF BMI OVER 35-38, THEY PREFER TO DO ROBOTIC TAPP. DR. [C]: THIS SURGEON HAS THE HIGHEST FREQUENCY OF ISSUES. THEY BELIEVE THAT THE C0H11, EITHER DURING INSERTION OR INFLATION, CAUSES TEARING OF THE PERITONEUM. CLAIMS THAT 1 IN 3 USES RESULTS IN PERITONEAL DEFECT. INTERVENTION: SURGEON REPAIRED TEAR/HOLE. PATIENT STATUS: PERITONEAL TEAR/HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727127 C0H11, KII DISSECTING BALLOON, OVL, 3/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES C0H11 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other