REFLEX 530Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30653405074810), received between May 26, 2017 and May 22, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2023Material Twisted/Bent; Material Twisted/Bent

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE 530 REFLEX ELC,20M/L CLIPS WERE BEING USED ON (B)(6) 2023 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE AND THE CLIPS "DID NOT LOAD STRAIGHT PROPERLY FROM THE BEGINNING.¿ THERE WAS NO IMPACT OR INJURY TO PATIENT/USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE AND THERE WAS NO DELAY. FURTHER INFORMATION WAS RECEIVED AND IT WAS FOUND THAT THE CLIPS WERE SCISSORING. "THE CLIP CAME OUT CROSSED. THE EVENT WAS AWARE WHEN THE DEVISE WAS USED ON A PATIENT." NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED STAY FOR THE PATIENT WAS REPORTED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16972910 ↗
• MalfunctionDec 27, 2022Firing Problem; Firing Problem

  UPDATE: PER ASSESSMENT THE PROCEDURE WAS A LAPAROSCOPIC CHOLECYSTECTOMY. THE PROCEDURE WAS COMPLETED WITH A 5 MINUTE DELAY. THE CLIPS DID NOT FALL INTO THE SURGICAL SITE. THE PATIENT IS "OK". THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED STAY AT THE HOSPITAL REQUIRED FOR THE PATIENT. THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 530, REFLEX ELC,20M/L CLPS,10/11MM WAS BEING USED ON (B)(6) 2022 AND ¿THE CLIPS DO NOT CLOSE DURING THE SURGERY¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050325 ↗
• InjuryDec 13, 2022Material Twisted/Bent; Material Twisted/Bent

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 530, REFLEX ELC,20M/L CLPS,10/11MM DEVICE, WAS BEING USED DURING A ROBOTIC ABDOMINAL PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿IN THE PROCESS OF CONNECTING VESSELS OF COMMON HEPATIC ARTERY WITH THE REFLEX ELC CLIP 10 MM DURING ABDOMINAL SURGERY USING ROBOT, THE ATTACHED PHOTO APPEARED AND RUPTURED THE COMMON HEPATIC ARTERY. IT WAS SUTURED IMMEDIATELY BUT IT WAS A VERY DANGEROUS SITUATION. DURING 6 HOURS OF SURGERY, THERE WAS 200 CC OF BLEEDING.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿THE BACK OF THE CLIP WAS BENT AND THAT BENT PART CAUSED THE HEPATIC ARTERY TO RUPTURE AND CAUSED BLEEDING.¿ THE PROCEDURE WAS COMPLETED, WITH AN UNKNOWN AMOUNT OF DELAY. THE PATIENT WAS HOSPITALIZED FOR AN UNKNOWN AMOUNT OF TIME AND THE PATIENT¿S CURRENT STATUS WAS REPORTED AS ¿PATIENT IS NOW HEALED.¿ IT IS UNKNOWN IF ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO PATIENT¿S HEPATIC ARTERY RUPTURING CAUSING A LOSS OF BLOOD, WHICH LET TO EXTENDED HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15970776 ↗
• MalfunctionNov 2, 2022Material Twisted/Bent; Material Twisted/Bent

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 530, REFLEX ELC, 20M/L CLPS, 10/11MM, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, WHEN IT WAS REPORTED, ¿WHEN IT IS CLIPPED SEVERAL TIMES FROM THE START OF USE, IT IS FREQUENTLY TWISTED AND CLIPPED, MAKING IT UNUSABLE.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THERE WAS NO PATIENT OR USER IMPACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713532 ↗
• InjuryApr 1, 2021Failure to Align; Failure to Align

  THE CUSTOMER REPORTED THAT THE DEVICE, 530, WAS BEING USED DURING AN ENDOSCOPIC GASTRECTOMY ON (B)(6) 2020 WHEN THE "CLIP WAS NOT ABLE TO CLOSE PROPERLY A BLOOD VESSEL WAS DAMAGED AND BLEEDING." THIS OCCURRED DURING THE SURGERY AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THE SURGEON STATES THAT THE PATIENT SUSTAINED DAMAGE TO A VESSEL. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE PATIENT SUSTAINING DAMAGE TO VESSEL.

  Patient problems: Perforation of Vessels

  MAUDE report 11601538 ↗
• InjuryMay 26, 2017Failure to Form Staple; Failure to Form Staple

  THE END-USER FACILITY REPORTED THAT WHILE USING THE REFLEX® ELC LAPAROSCOPIC CLIP APPLIER IN A CHOLECYSTECTOMY, THE CLIP WAS NOT COMPLETELY CLOSED AFTER THE APPLICATION. THE CLIP BECAME LOST, BUT WAS ABLE TO BE RETRIEVED. THIS HAPPENED WITH TWO SEPARATE DEVICES. TO DATE THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED. THIS REPORT IS RAISED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6593988 ↗