ECHELON Flex ENDOPATH PLE60ARecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705036014300), received between Sep 4, 2013 and Sep 17, 2026 — classified as 6 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (11 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Failure to Cut; Difficult to Open or Close

  It was reported that during a Gastroplasty procedure, it was observed that the device had an unspecified malfunction. There was no patient consequence nor surgical delay reported. Additional information requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50807215 ↗
• MalfunctionOct 22, 2025Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE PLEE60 MISFIRED; AND THE GST60B AND JAW WERE STUCK. THE DOCTOR HAD TO DO MANUAL OVERRIDE TO OPEN THE JAW. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358452 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE OF SLEEVE GASTROPLASTY, THERE WAS BLEEDING IN THE LINE OF STAPLES. THE SURGERY OCCURRED WITHOUT IMMEDIATE COMPLICATIONS, HOWEVER, IN THE POST-ANESTHETIC RECOVERY ROOM, THE PATIENT PRESENTED SIGNS OF INSTABILITY, WITH VISIBLE BLEEDING THROUGH THE DRAIN. IN VIEW OF THE PICTURE, THE DOCTOR CHOSE TO PERFORM A SURGICAL REAPPROACH, THROUGH A LAPAROTOMY. IN THE REOPERATION, ARTERIAL BLEEDING WAS IDENTIFIED IN THE LINE OF CLAMPS. IT WAS FOUND THAT ALL CLAMPS WERE PROPERLY CLOSED IN THE BLEEDING REGION. THUS, THE SURGEON PERFORMED AN OVERSTRUCTURED THROUGHOUT THE SLEEVE STAPLE LINE. CURRENTLY, THE PATIENT IS IN THE ICU, IN A STABLE STATE, WITH NO EVIDENCE OF NEW BLEEDING. THERE WERE KIDNEY CHANGES SECONDARY TO HEMORRHAGIC SHOCK, BUT BLEEDING WAS CONTROLLED, AND THE PATIENT REMAINS IN RECOVERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22386205 ↗
• MalfunctionAug 16, 2023Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, THE DEVICE ANVIL WAS BENT ON 3RD FIRE AND COULDN'T CLAMP ON TROCAR. NEW ONE WAS USED TO COMPLETE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560198 ↗
• MalfunctionAug 15, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE GRIPPING OF THE HANDLE WAS VERY TIGHT LOCKING IT IN BETWEEN THE SURGERY. THE SURGERY WAS NOT DELAYED AND I NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549972 ↗
• MalfunctionMar 28, 2023Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  IT WAS REPORTED THAT DURING THE SURGERY. AFTER THE FIFTH FIRED, THE SURGEON NOTED THAT THE TISSUE WAS NOT CUT AND STAPLES DEPLOYED ON THE TISSUE, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER DEVICE TO COMPLETE THE PROCEDURE, THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630452 ↗
• MalfunctionSep 20, 2022Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT THE BLADE OF GUN GOT STUCK THE MANUAL OVER RIDE WAS USED TO BRING THE BACK TO PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15458836 ↗
• MalfunctionApr 1, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT A SURGEON WAS USING ECHELON FLEX POWERED CUTTER FOR A BARIATRIC PROCEDURE. IT STOPS WORKING AFTER 4 FIRINGS. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13980079 ↗
• MalfunctionApr 1, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE SURGEON WAS USING ECHELON FLEX POWERED CUTTER FOR A BARIATRIC PROCEDURE. IT STOPS WORKING AFTER 4 FIRINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979984 ↗
• MalfunctionApr 1, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE SURGEON WAS USING ECHELON FLEX POWERED CUTTER FOR A BARIATRIC PROCEDURE. IT STOPS WORKING AFTER 4 FIRINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978180 ↗
• MalfunctionMar 15, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC SLEEVE PROCEDURE, THE DOCTOR WAS FIRING ON THE STOMACH. IT CUT BUT DID NOT STAPLE. HE WAS FIRING WITH A GREEN RELOAD USING GORE SEAM GUARD BRAND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13773891 ↗
• MalfunctionAug 4, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE GREEN STAPLE OF ECHELON 60 STAPLER FOR FAILURE OF GASTRIC SLEEVE PROCEDURE. THE GREEN STAPLE BROKE INTO TWO PARTS AND THE DOCTOR DECIDED TO REPLACE THE STAPLE WITH A NEW ONE. DEVICE FAILURE DID NOT CAUSE A DELAY IN SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276657 ↗
• MalfunctionMay 28, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, AFTER SEVERING GASTRIC TISSUE ON THE THIRD FIRING, IT WAS NOTED THAT STAPLES WERE MALFORMED WITH IRREGULAR SHAPES. CHANGED TO A NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10098712 ↗
• InjuryApr 10, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THE ECHELON STOPS WORKING, APPARENTLY THE BATTERY HAS RUN OUT. THEY MUST OPEN AND REVERSE THE BLADE MANUALLY. THE ECHELON CUT BUT NOT STAPLE. THEY CHANGED THE ECHELON TO CONTINUE THE SURGERY, BUT THEY HAD TO CONVERT TO OPEN SURGERY DUE TO BLEEDING. THEY HAD TO REOPERATE FOR BLEEDING SOMEWHERE ELSE (NEAR THE SPLEEN) ON SUNDAY AT 1:00 PM.

  Patient problems: Blood Loss

  MAUDE report 9948161 ↗
• MalfunctionFeb 10, 2020Activation, Positioning or Separation Problem

  SURGEON WAS PERFORMING A GASTRIC BYPASS. WHEN FIRING A BLUE CARTRIDGE, HE SAW MUCOSAL TISSUE GOING OUT SUDDENLY FROM THE CARTRIDGE LINE, AS IF IT WAS WEEK OR IF THERE WAS NO STAPLES. THE SURGEON HAD TO REPAIR THE CARTRIDGE LINE AND PUT A DRAIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9686918 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR PRESENTED SOME CASES OF BLEEDING WITH OUR TECHNOLOGIES. THEY REPORT THAT THE ECHELON STAPLE LINE HAS BEEN BLEEDING A LOT AND THIS LEADS TO A LONGER SURGICAL TIME SINCE THEY NEED TO CONTAIN THIS SHROUD WITH THE USE OF VARIOUS GAUZE, CLIPS AND OVERLAYS, ACTIONS THEY DO NOT DEEM NECESSARY WHEN USING COMPETITOR¿S MATERIALS. PATIENTS, IN GENERAL, END UP EVOLVING WELL. SOME HAVE MELENA (BLOOD IN THE STOOL) AND ONLY 1 NEEDED TO BE REOPENED DUE TO BLEEDING ON THE SECOND POSTOPERATIVE DAY. IN THIS CASE, THE CAVITY WAS CLEANED AND THE PATIENT HAD TO RECEIVE 2 BAGS OF BLOOD. SHE SPENT 1 DAY IN THE ICU, JUST IN CASE AND WAS DISCHARGED ON THE FOURTH DAY (2 DAYS LONGER THAN NORMAL).

  Patient problems: Blood Loss; No Code Available; Not Applicable

  MAUDE report 9648275 ↗
• MalfunctionDec 18, 2019Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BLADE DID NOT MOVE. SURGERY WAS NOT DELAYED. DOCTOR USED A NEW GUN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490182 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM, POST-OP, FROM THE POST ANESTHETIC RECOVERY ROOM, DUE TO SUSPECTED BLEEDING AFTER A LAPAROSCOPIC SLEEVE GASTRECTOMY. DURING THE SECOND PROCEDURE, IT WAS CONFIRMED THAT A GASTRIC VESSEL WAS BLEEDING THROUGH THE STAPLE LINE, AND A CLIP WAS PLACED ON THE BLEEDING SITE TO ACHIEVE HEMOSTASIS. NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT THEN PROCEEDED TO POST-OP RECOVERY AS PER NORMAL. A COMBINATION OF GST60D AND GST60B RELOAD CARTRIDGES WERE USED IN THE INITIAL PROCEDURE, IN ACCORDANCE WITH TISSUE THICKNESS. THE SURGEON WAITED 10-15 SECONDS AFTER CLOSING THE DEVICE BEFORE FIRING THE STAPLER EACH TIME DURING THE PROCEDURE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9323655 ↗
• MalfunctionSep 23, 2019Retraction Problem

  IT WAS REPORTED THAT AFTER SHOOTING THE STAPLER, THE BLADE DID NOT RETURN, THE REVERSE WAS TRIGGERED AND STILL DID NOT RETURN. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9103943 ↗
• MalfunctionSep 17, 2019Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DOCTOR WAS PERFORMING SURGERY AND AFTER TWO RELOADS, GUN WAS NOT OPENED. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079790 ↗
• MalfunctionJun 3, 2019Retraction Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, WHEN DOCTOR USE THE DEVICE, WHEN FIRING THE DEVICE BLADE CANNOT BE RETRACTED TO ITS ORIGINAL POSITION, SO USE MANUAL RETRACTION. UNKNOWN IF THE PROCEDURE WAS DELAYED. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663199 ↗
• MalfunctionMay 7, 2019Mechanical Problem; Retraction Problem

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC SLEEVE GASTRECTOMY SURGERY,AFTER FIRED, THE KNIFE MOVED TO THE DISTAL END, BUT COULD NOT RETURN KNIFE AUTOMATICALLY. KNIFE REVERSE BUTTON COULD NOT WORK. USED MANUAL OVERRIDE LEVER TO RETURN KNIFE. OPENED THE DEVICE MANUALLY WITH BIG FORCE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8585989 ↗
• MalfunctionMar 13, 2019Break

  IT WAS REPORTED THAT WE HAD AN PROCEDURE IN THE AFTERNOON WHERE AN ECHELON PLE60A WAS USED THAT HAD A PIECE (FRAGMENT) THAT WE DID NOT KNOW AND DID NOT ALLOW TO PUT THE CARTRIDGE. THEREFORE THE CARTRIDGE WAS NOT USED EITHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416414 ↗
• MalfunctionJan 29, 2019Mechanical Problem

  IT WAS REPORTED THAT DURING THE BARIATRIC SURGERY,AFTER FIRED, THE KNIFE MOVED TO THE DISTAL END, BUT COULD NOT RETURN KNIFE AUTOMATICALLY. KNIFE REVERSE BUTTON COULD NOT WORK. THE SURGEON REMOVED THE BATTERY AND ROTATED FOR 180 DEGREE AND REINSERTED THE BATTERY, BUT KNIFE REVERSE BUTTON STILL COULD NOT WORK. USED MANUAL OVERRIDE LEVER TO RETURN KNIFE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285216 ↗
• MalfunctionDec 18, 2018Firing Problem

  AFTER THE THIRD SHOT THE STAPLER LOCKED, THE REVERSE DID NOT WORK. THEY OPENED A NEW STAPLER AND CONTINUED THE SURGERY. THERE WAS NO HARM TO THE PATIENT. NO FURTHER DESCRIPTIONS OF THE EVENT. PROCEDURE: LAPAROSCOPIC RADICAL CISTECTOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174218 ↗