Epix® Universal Clip Applier CA500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,183 adverse event reports that list this exact device (DI 00607915125318), received between Jan 25, 2016 and Sep 30, 2026 — classified as 1 death, 24 injuries, 1,158 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (624 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 30, 2024Open, Classified

   Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

   Z-1388-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,183 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fluid/Blood Leak

  Patient problems: Biliary Leak

  MAUDE report 50947549 ↗
• MalfunctionSep 10, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724273 ↗
• MalfunctionSep 3, 2026Fluid/Blood Leak

  Name of Procedure: Lap CholeEvent Description:Additional information provided via phone by an Applied Medical representative on 07AUG2026: Once clip placed on artery, it was loose. You can actually move the clip. It had a wiggle. This is not the first time it has happened, but we wanted to give the product a fair chance.Additional information provided via email by an Applied Medical representative on 12AUG2026:Dr. (b)(6)]" did not mention that she had any leakeage. In the meeting, she stated that she had a clip scissored on the duct. She took it out, fired the device again and it closed properly. I asked if she had any situations with the closure of the tip and she answered that at times she sees that the clip does not closes well at the apex but in this case it closed properly.Please note that the information entered under Dr. (b)(6) actually was said by Dr. (b)(6). What Dr. (b)(6) did do is agree to his statement. I asked why she agreed, and she responded that it has happened to her but when it does she takes it out and fires again the device. This was reported not within the time frame expected. Months after. Therefore they cant recall.No leakage.The event date is unknown. Inter

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50594094 ↗
• MalfunctionAug 31, 2026Failure to Align; Failure to Form Staple

  Clip applier misaligning clips after 2-3 firings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525861 ↗
• MalfunctionAug 31, 2026Mechanical Jam

  clip applier jammed during application.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525649 ↗
• MalfunctionAug 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508284 ↗
• MalfunctionAug 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507806 ↗
• MalfunctionJul 20, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883847 ↗
• MalfunctionJul 15, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25828997 ↗
• MalfunctionJun 9, 2026Failure to Fire

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: THE CUSTOMER CALLED AND WANTED TO FILE A COMPLAINT REGARDING ITEM CA500 LOT# 1557343 THAT MISSED FIRED ON 5/8/25. CONTACT [NAME] [EMAIL] [PHONE NUMBER] ADDITIONAL INFORMATION PROVIDED BY [CONTACT NAME] ON 09JUN2026: IT WAS 05/08/26. I HAVE SPOKEN TO THE STAFF AND I/VE GOTTEN THE RUN AROUND ABOUT WHO WAS IN THE ROOM. I¿VE SENT THEM YOUR EMAIL ASKING THEM TO COMPLETE THE QUESTIONS AND NO RESPONSE. SO I THINK IT¿S FORGOTTEN ABOUT. INTERVENTION: NI PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446298 ↗
• MalfunctionJun 2, 2026Failure to Fire

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: [HOSPITAL] "DURING USE, THERE WAS A PROBLEM WITH SHOOTING." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2026 FROM [NAME], TERRITORY MANAGER: "THE ¿LOADING THE CLIP¿ ACTION WAS BEING PERFORMED WHEN THE EXPERIENCE OCCURRED. THE INSTRUMENT ¿MISFIRED¿ IN THAT IT WAS STRUCK WHEN THE TRIGGER WAS PULLED. A TOTAL OF 3¿4 CLIPS WERE DISPENSED. THE INCIDENT OCCURRED WITH 1¿2 CLIPS. WHEN IT STRUCK, THE SURGEON DID NOT TRY TO FIX IT ANYMORE BECAUSE IT COULD MISFIRE WHEN THE CLIP APPLIER IS INSIDE PERITONEUM." INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE. PATIENT STATUS: THERE WAS NO PROBLEM WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25367695 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak; Failure to Fire; Failure to Seal

  PROCEDURE PERFORMED: CHOLECYSTECTOMY EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. IN THE REVISION PRIOR THE SURGERY, THE CLIP WAS DELIVERED WITH A DEFORMATION. BY THE SECOND REVISION THE CLIPS WERE STUCK IN THE RELEASE AREA. SERVICE DESCRIPTION - REQUESTED INSPECTION (PERFORMED BY HOSPITAL FROM (B)(6) 2026): A TECHNICAL VERIFICATION WAS PERFORMED ON AN EPIX MODEL CA500 UNIVERSAL DISPOSABLE CLIP APPLIER, CORRESPONDING TO LOT 1561350, FOLLOWING AN INCIDENT REPORTED DURING A SURGICAL PROCEDURE INVOLVING PATIENT [NAME]. DURING THE SURGICAL PROCEDURE, MEDICAL PERSONNEL REPORTED ANOMALOUS BEHAVIOR OF THE DEVICE¿SPECIFICALLY REGARDING THE CLIP RELEASE MECHANISM¿EVIDENCING THE EJECTION OF AT LEAST ONE DEFORMED CLIP, WHICH COMPROMISES ITS PROPER APPLICATION AND FIXATION ONTO THE TISSUE. ADDITIONALLY, PERSONNEL REPORTED THAT THE TWO DEVICES OF THE SAME MODEL REQUESTED FOR THE PROCEDURE¿BOTH BELONGING TO LOT 1561350¿EXHIBITED THE SAME IRREGULAR BEHAVIOR. AS A RESULT OF THIS SITUATION, THE DECISION WAS MADE TO REPLACE THEM AND CONTINUE THE PROCEDURE USING AN ALTERNATE DEVICE PROVIDED BY THE MEDICAL PERSONNEL THEMSELVES. AS PART OF THE POST-EVENT ANALYSIS, A FUNCTIONAL VERIFICATION WAS CONDUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166960 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak; Failure to Fire; Failure to Seal

  PROCEDURE PERFORMED: CHOLECYSTECTOMY EVENT DESCRIPTION: IN THE REVISION PRIOR THE SURGERY, THE CLIP WAS DELIVERED WITH A DEFORMATION. BY THE SECOND REVISION THE CLIPS WERE STUCK IN THE RELEASE AREA. SERVICE DESCRIPTION - REQUESTED INSPECTION (PERFORMED BY HOSPITAL FROM (B)(6) 2026 TO (B)(6) 2026): A TECHNICAL VERIFICATION WAS PERFORMED ON AN EPIX MODEL CA500 UNIVERSAL DISPOSABLE CLIP APPLIER, CORRESPONDING TO LOT 1561350, FOLLOWING AN INCIDENT REPORTED DURING A SURGICAL PROCEDURE INVOLVING PATIENT [NAME] (EPISODE 738681). DURING THE SURGICAL PROCEDURE, MEDICAL PERSONNEL REPORTED ANOMALOUS BEHAVIOR OF THE DEVICE¿SPECIFICALLY REGARDING THE CLIP RELEASE MECHANISM¿EVIDENCING THE EJECTION OF AT LEAST ONE DEFORMED CLIP, WHICH COMPROMISES ITS PROPER APPLICATION AND FIXATION ONTO THE TISSUE. ADDITIONALLY, PERSONNEL REPORTED THAT THE TWO DEVICES OF THE SAME MODEL REQUESTED FOR THE PROCEDURE¿BOTH BELONGING TO LOT 1561350¿EXHIBITED THE SAME IRREGULAR BEHAVIOR. AS A RESULT OF THIS SITUATION, THE DECISION WAS MADE TO REPLACE THEM AND CONTINUE THE PROCEDURE USING AN ALTERNATE DEVICE PROVIDED BY THE MEDICAL PERSONNEL THEMSELVES. AS PART OF THE POST-EVENT ANALYSIS, A FUNCTIONAL VERIFICATION WAS CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166871 ↗
• MalfunctionMay 7, 2026Failure to Fire

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: AT THE BEGINNING OF THE SURGERY, EVERY OTHER CLIP FAILED TO LOAD (DID NOT LOAD), AFTER USING 5-10 CLIPS THE DEVICE WORKED NORMALLY. NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON (B)(6) 2026: THIS HAS HAPPENED ALREADY ON (B)(6). INTERVENTION: UNKNOWN. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116159 ↗
• MalfunctionApr 30, 2026Failure to Fire

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: [HOSPITAL]. (THIS EVENT WAS DIRECTLY REPORTED TO MFDS BY [HOSPITAL], BUT THE EVENT OCCURRED AT [HOSPITAL]. SINCE TWO HOSPITALS ARE PARTNER HOSPITAL (BOTH AFFILIATED WITH [UNIVERSITY]), IT WAS REPORTED BY [HOSPITAL] THAT HAS ADVERSE EVENT REPORTING CENTER.) "THE CLIP WAS NOT LOADED." INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050193 ↗
• MalfunctionApr 22, 2026Failure to Fire

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. THE CUSTOMER REPORTED THAT ABOUT FIVE OR SIX DIFFERENT CLIP APPLIERS (LIKELY FROM THE SAME LOT) DID NOT DEPLOY THE FIRST (OR FIRST AND SECOND CLIP) CORRECTLY. THERE WAS EITHER NO CLIP OR A DAMAGED CLIP. AFTER SOME "PLASTIC TO PLASTIC" USAGES THE FOLLOWING CLIPS WORKED JUST FINE. THE PHYSICIANS ARE TRAINED TO USE THE CLIP APPLIER CORRECTLY AND THEY ARE NOT PRELOADING THE CLIPAPPLIER BEFORE ENTERING THE TROCAR. I TALKED TO THE CHIEF PHYSICIAN ABOUT THOSE INCIDENTS AND HE ASSURED ME THAT HE HAS BEEN USING THE CLIP APPLIERS THE SAME WAY HE ALWAYS HAD. NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 13APR26: THE CUSTOMER PURCHASED IT AS A KIT. EVENT DATES ARE DIFFERENT, BASICALLY IN THE 3 WEEKS PRIOR TO THE EVENT DATE. I CAN NOT CONFIRM IF ALL THE INCIDENT DEVICES BELONGED TO LOT 1559037. BUT THE CUSTOMER TOLD ME THAT THEY NEVER HAD ISSUES BEFORE OR AFTER. THEY THINK THEY ALL BELONGED TO THE SAME LOT. I CAN NOT CLARIFY IT THOUGH. 4 OF THE CLIP APPLIERS DID NOT APPLY ANY CLIPS FOR THE FIRST FEW "PLASTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960653 ↗
• MalfunctionApr 22, 2026Failure to Fire

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. THE CUSTOMER REPORTED THAT ABOUT FIVE OR SIX DIFFERENT CLIP APPLIERS (LIKELY FROM THE SAME LOT) DID NOT DEPLOY THE FIRST (OR FIRST AND SECOND CLIP) CORRECTLY. THERE WAS EITHER NO CLIP OR A DAMAGED CLIP. AFTER SOME "PLASTIC TO PLASTIC" USAGES THE FOLLOWING CLIPS WORKED JUST FINE. THE PHYSICIANS ARE TRAINED TO USE THE CLIPAPPLIER CORRECTLY AND THEY ARE NOT PRELOADING THE CLIPAPPLIER BEFORE ENTERING THE TROCAR. I TALKED TO THE CHIEF PHYSICIAN ABOUT THOSE INCIDENTS AND HE ASSURED ME THAT HE HAS BEEN USING THE CLIP APPLIERS THE SAME WAY HE ALWAYS HAD. NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 13-APR-2026: THE CUSTOMER PURCHASED IT AS A KIT. EVENT DATES ARE DIFFERENT, BASICALLY IN THE 3 WEEKS PRIOR TO THE EVENT DATE. I CAN NOT CONFIRM IF ALL THE INCIDENT DEVICES BELONGED TO LOT 1559037. BUT THE CUSTOMER TOLD ME THAT THEY NEVER HAD ISSUES BEFORE OR AFTER. THEY THINK THEY ALL BELONGED TO THE SAME LOT. I CAN NOT CLARIFY IT THOUGH. 4 OF THE CLIP APPLIERS DID NOT APPLY ANY CLIPS FOR THE FIRST FEW "PL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960623 ↗
• MalfunctionApr 22, 2026Failure to Fire

  PROCEDURE PERFORMED: CHOLECYSTECTOMY. EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 5-JAN-2026: NO PATIENT INJURY OCCURRED AS A RESULT OF THIS EVENT. PATIENT STATUS OK. RESOLVE THE SITUATION: USE ANOTHER ONE. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 17-MAR-2026: TM CONFIRMS THE LOT AS 1542695. INTERVENTION: USE ANOTHER ONE. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958506 ↗
• MalfunctionApr 16, 2026Failure to Fire

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: THE FIRST CLIP WAS RELEASED WITHOUT ANY PROBLEMS AND SEATED VERY WELL. THE SURGEON ATTEMPTED TO CLIP THE CYSTIC DUCT A SECOND TIME, BUT NO CLIP WAS RELEASED DESPITE REPEATED ATTEMPTS. IT WAS ONLY AFTER THE FOURTH ATTEMPT THAT THE CLIP WAS RELEASED. THIS INCIDENT OCCURRED ON THREE SEPARATE OCCASIONS. NO CHANGE OF INSTRUMENT WAS REQUIRED TO COMPLETE THE PROCEDURE; HOWEVER, THERE WAS A RESULTING LOSS OF TIME. INTERVENTION: NO CHANGE OF INSTRUMENT WAS REQUIRED TO COMPLETE THE PROCEDURE; HOWEVER, THERE WAS A RESULTING LOSS OF TIME. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902235 ↗
• MalfunctionApr 16, 2026Failure to Fire

  PROCEDURE PERFORMED: APPENDECTOMY. EVENT DESCRIPTION: THE INSERTION OF THE FIRST CLIP WENT SMOOTHLY. HOWEVER, WHEN THE SURGEON ATTEMPTED TO INSERT A SECOND CLIP, NONE EMERGED FROM THE DEVICE DESPITE SEVERAL ATTEMPTS TO ACTIVATE THE HANDLE. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 07APR26: CORRECT LOT NUMBER 1558942. INTERVENTION: NI. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901940 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: WHEN PLACING THE CLIPS TO CLAMP THE CYSTIC DUCT: THE CLIPS REMAINED OPEN AND FAILED. CONSEQUENTLY, THE CYSTIC DUCT OPENED, BILE LEAKED INTO THE ABDOMINAL CAVITY, THE DURATION OF THE PROCEDURE WAS PROLONGED, AND THERE WAS AN INCREASED RISK OF A POST-OPERATIVE ABSCESS. THE STAPLER WAS CHANGED (TO A NON-AUTOMATIC STAPLER AND CLIP CARTRIDGES) TO CONTINUE THE PROCEDURE. INTERVENTION: THE STAPLER WAS CHANGED (TO A NON-AUTOMATIC STAPLER AND CLIP CARTRIDGES) TO CONTINUE THE PROCEDURE. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901687 ↗
• MalfunctionApr 1, 2026Failure to Fire

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: THE DEVICE WAS BEING USED TO CLIP A VESSEL AND IT WOULD NOT RELOAD THE CLIP. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. NO HARM DONE TO THE PATIENT. THE USER RESOLVED THE SITUATION BY OPENING ANOTHER CLIP APPLIER. THE OTHER INSTRUMENTS USED AT THE TIME WAS STANDARD KIT FOR LAP CHOLE. ADDITIONAL INFORMATION WAS PROVIDED BY [TERRITORY MANAGER] VIA EMAIL ON 18-MAR-2026: "THE HOSPITAL DOES NOT USE APPLIED MEDICAL LAP CHOLE KITS, THEY MAKE UP THEIR OWN." INTERVENTION: THEY RESOLVED THE SITUATION BY OPENING ANOTHER APPLIER. PATIENT STATUS: NO HARM DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757186 ↗
• MalfunctionMar 30, 2026Failure to Fire

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: WHEN THEY TRIED THE CLIP APPLIER, THERE WAS INSIDE ONLY ONE CLIP. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA TEAMS CALL ON 10MAR26: ALL THE EVENTS TOOK PLACE ON MARCH 8TH BEFORE USE. (B)(4) DEVICES FROM LOT 1560548 HAD THE SAME PROBLEM (ONLY ONE CLIP WAS INSIDE THE DEVICE) AND THEY WERE DISCARDED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17MAR26: I¿VE JUST CHECKED AND THE CORRECT LOT NUMBER IS 1567140. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 19MAR26: THE USER RESOLVED THE SITUATION CHANGING DEVICE. ONLY ONE CLIP LOADED INTO THE JAWS.12 MM TROCAR WAS USED. THE CLIP WAS LOADED AND VISIBLE BETWEEN THE JAWS OF THE DEVICE, AND IT WAS PROPERLY SEATED. NO (REGARDING CLIP LOADED INTO THE JAWS PRIOR TO THE INSTRUMENT¿S INSERTION/REMOVAL THROUGH THE TROCAR) BECAUSE THEY TRIED IT BEFORE PUTTING INSIDE THE TROCAR. THE ACTUATION COMPLETED BY FULLY SQUEEZING THE TRIGGER ¿PLASTIC TO PLASTIC¿ AND ALLOWING THE INSTRUMENT TO REST. NO LOADED CLIP WAS MANUALLY REMOVED FROM THE JAWS. THEY TRIED AGAIN, BUT IT WAS EMPTY. NO OTHER CLIP INSIDE. LIKE ALWAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721642 ↗
• MalfunctionMar 30, 2026Failure to Fire

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: WHEN THEY TRIED THE CLIP APPLIER, THERE WAS INSIDE ONLY ONE CLIP. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA TEAMS CALL ON 10MAR26: ALL THE EVENTS TOOK PLACE ON MARCH 8TH BEFORE USE. 4 DEVICES FROM LOT 1560548 HAD THE SAME PROBLEM (ONLY ONE CLIP WAS INSIDE THE DEVICE) AND THEY WERE DISCARDED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17MAR26: I¿VE JUST CHECKED AND THE CORRECT LOT NUMBER IS 1567140. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 19MAR26: THE USER RESOLVED THE SITUATION CHANGING DEVICE. ONLY ONE CLIP LOADED INTO THE JAWS.12 MM TROCAR WAS USED. THE CLIP WAS LOADED AND VISIBLE BETWEEN THE JAWS OF THE DEVICE, AND IT WAS PROPERLY SEATED. NO (REGARDING CLIP LOADED INTO THE JAWS PRIOR TO THE INSTRUMENT¿S INSERTION/REMOVAL THROUGH THE TROCAR) BECAUSE THEY TRIED IT BEFORE PUTTING INSIDE THE TROCAR. THE ACTUATION COMPLETED BY FULLY SQUEEZING THE TRIGGER ¿PLASTIC TO PLASTIC¿ AND ALLOWING THE INSTRUMENT TO REST. NO LOADED CLIP WAS MANUALLY REMOVED FROM THE JAWS. THEY TRIED AGAIN, BUT IT WAS EMPTY. NO OTHER CLIP INSIDE. LIKE ALWAYS, TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721313 ↗
• MalfunctionMar 30, 2026Failure to Fire

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: WHEN THEY TRIED THE CLIP APPLIER, THERE WAS INSIDE ONLY ONE CLIP. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA TEAMS CALL ON 10MAR26: ALL THE EVENTS TOOK PLACE ON MARCH 8TH BEFORE USE. 4 DEVICES FROM LOT 1560548 HAD THE SAME PROBLEM (ONLY ONE CLIP WAS INSIDE THE DEVICE) AND THEY WERE DISCARDED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 17MAR26: I¿VE JUST CHECKED AND THE CORRECT LOT NUMBER IS 1567140. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 19MAR26: THE USER RESOLVED THE SITUATION CHANGING DEVICE. ONLY ONE CLIP LOADED INTO THE JAWS.12 MM TROCAR WAS USED. THE CLIP WAS LOADED AND VISIBLE BETWEEN THE JAWS OF THE DEVICE, AND IT WAS PROPERLY SEATED. NO (REGARDING CLIP LOADED INTO THE JAWS PRIOR TO THE INSTRUMENT¿S INSERTION/REMOVAL THROUGH THE TROCAR) BECAUSE THEY TRIED IT BEFORE PUTTING INSIDE THE TROCAR. THE ACTUATION COMPLETED BY FULLY SQUEEZING THE TRIGGER ¿PLASTIC TO PLASTIC¿ AND ALLOWING THE INSTRUMENT TO REST. NO LOADED CLIP WAS MANUALLY REMOVED FROM THE JAWS. THEY TRIED AGAIN, BUT IT WAS EMPTY. NO OTHER CLIP INSIDE. LIKE ALWAYS, TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721294 ↗