ILA 3971Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10884521063167), received between Oct 16, 2017 and Apr 13, 2021 — classified as 10 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (8 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2021Break; Failure to Cut; Break; Failure to Cut

  ACCORDING TO THE REPORTER, DURING OPEN ABDOMINAL SURGERY, THE TISSUE WAS STAPLED, BUT THE CUTTER DID NOT MOVE WELL. THE DEVICE BROKE AND THE CUTTER GOT DAMAGED. IT WAS CUT WITH ELECTROSURGICAL KNIFE TO SOLVE THE PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656876 ↗
• InjuryAug 28, 2020Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE TRANSECTION OF THE TISSUE ON A J-POUCH SURGERY, AFTER FIRING THE SURGEON NOTICED AN INCOMPLETE STAPLE LINE AND POOR STAPLE FORMATION. THE SURGEON OVERSEW THE STAPLE LINE TO RESOLVE THE ISSUE. IT WAS NOTICED THAT THE STAPLER HAD NOT BEEN LOADED PROPERLY BY THE SCRUB TECHNICIAN.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10469222 ↗
• MalfunctionMar 23, 2020Material Separation; Misfire; Failure to Cut; Material Separation; Misfire; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A DISTAL GASTRECTOMY, THE CARTRIDGE WAS ATTACHED TO THE STAPLER, AND WHEN AN ATTEMPT WAS MADE TO FIRE THE DEVICE ON THE STOMACH, THE STAPLES CAME OUT BY FIRING, THE KNIFE WAS NOT PUSHED OUT. THE DEVICE COULD NOT BE USED. AS FAR AS THE SAMPLE WAS SEEN, MOST OF THE STAPLES HAVE BEEN FIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN THIRTY MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9864198 ↗
• MalfunctionMar 17, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING DISTAL GASTRECTOMY, THE DEVICE STOPPED WORKING IN THE MIDDLE OF THE PROCEDURE AT THE TIME OF FIRING. IT WAS NOTED THAT SURGICAL TIME WAS EXTENDED LESS THAT FIVE MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9842985 ↗
• MalfunctionJan 20, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PROXIMAL GASTRECTOMY, WHEN USING THE LOADING UNIT, IT WAS TOO STIFF AND THE KNIFE DID NOT MOVE. THE SURGEON TRIED TO FIRE ON NOTHING WITHOUT TISSUE CLAMPED, BUT THE KNIFE STILL DID NOT MOVE AT ALL. WHEN USING ANOTHER LOADING UNIT, THE KNIFE BENT AND COULD NOT CUT AT ALL HOWEVER, THE STAPLES HAVE BEEN PROPERLY FORMED UNTIL THE END. THEY WERE NOT ABLE TO CUT WITH THE KNIFE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9607222 ↗
• MalfunctionDec 30, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING CLOSURE OF THE ANASTOMOSES IN A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, THERE WAS POOR STAPLE FORMATION. THE STAPLE LINE ON THE TISSUE THAT WAS LEFT IN THE PATIENT'S CAVITY LOOKED GOOD, BUT THE STAPLE LINE ON THE SPECIMEN THAT WAS EXPLANTED WAS MALFORMED. THE STAPLES DID NOT APPEAR TO HAVE HIT THE ANVIL BUCKETS. THE STAPLE LEGS WERE STRAIGHT WITH NO SIGN OF B-FORMATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530252 ↗
• InjuryDec 30, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, ON THE SECOND FIRING TO CLOSE THE ANASTOMOSIS, ONE ROW OF THE STAPLES FORMED BUT THE SECOND ROW OF THE STAPLES PARTIALLY FORMED THE LAST 1/3 OF THE STAPLE LINE. THE STAPLE LINE WAS FIXED BY OVERSEWING.

  Patient problems: No Code Available

  MAUDE report 9530116 ↗
• InjuryNov 25, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC RIGHT COLON RESECTION, WHILE CLOSING THE ANASTOMOSIS, THE FORMATION OF THE STAPLES DISTALLY WAS POOR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE STAPLE LINE WAS OVER-SEWN, RESECTED, AND RESTAPLED.

  Patient problems: No Code Available

  MAUDE report 9368750 ↗
• MalfunctionOct 8, 2019Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING COLOSTOMY, THE KNIFE BAR BENT WHILE FIRING. IT WAS STATED THAT THE ISSUE OCCURRED SUCCESSIVELY IN 3 UNITS. THE JAWS CLAMPING THE SIGMOID COLON OF THE PATIENT WERE OPENED AND THE RELOAD WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9166858 ↗
• InjuryMay 1, 2019Break; Failure to Form Staple; Detachment of Device or Device Component; Break; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER ON A PARTIAL GASTRECTOMY, WHEN FIRING WAS PERFORMED DURING THE STOMACH RESECTION, THERE WERE MANY PARTS WHERE THE STAPLES WERE NOT FIRED ON THE TISSUE, AND MANUAL SUTURING WAS PERFORMED TO COMPLETE THE CASE. WHEN RETURNING THE KNIFE TO THE ORIGINAL POSITION, THE WIRE INSIDE THE STAPLER PROTRUDED, IT IS THE PART WHICH PUSH THE KNIFE OF THE CARTRIDGE OUT. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE DEVICE WAS REMOVED FROM THE TISSUE BY ADDITIONALLY RESECTING THE TISSUE. THERE WAS TISSUE DAMAGE. OOZING BLEEDING THAT IS LESS THAN 500CC OCCURRED AS A RESULT OF THE ISSUE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8571689 ↗
• InjuryJan 20, 2019Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A DURING FUNCTIONAL END-TO-END ANASTOMOSIS IN TRANSVERSE COLECTOMY. THE DEFECT OCCURRED WHEN CLOSING THE COMMON HOLE AFTER SIDE-BY-SIDE ANASTOMOSIS. AT THE FIRST FIRING, WHILE GRASPING THE TISSUE AND PROCEEDING THE FIRING, IT BECAME HARD FROM THE HALFWAY AND THE KNIFE BAR BECAME BENT ALTHOUGH THE FIRING ADVANCED TO THE END. WHEN OBSERVING THE TISSUE AFTER RELEASING THE DEVICE, IT WAS FOUND THAT THE STAPLES WERE APPLIED, BUT THE CUTTING WAS ONLY HALF WAY DONE. THE TISSUE THAT WAS NOT SEPARATED COMPLETELY WAS CUT WITH AN ELECTROSURGICAL KNIFE AND REINFORCED WITH THE NEEDLE AND THREAD, AND THE OPERATION WAS COMPLETED.

  Patient problems: No Code Available

  MAUDE report 8263233 ↗
• InjuryAug 30, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT CUT THE TISSUE. THE SURGEON STATED THAT WHEN THEY FIRED THE STAPLE THE KNIFE DID NOT CUT, BUT STAPLES DID A COMPLETE STAPLE LINE. THEY STATED THAT THE BLADE ¿BOWED¿ OUT FROM THE SHAFT FROM THE REUSABLE STAPLER. THEY STATED THIS HAPPENED WITH TWO DIFFERENT LOADS. THEY MANUALLY CUT BETWEEN THE STAPLES AND OVER SOWED THE STAPLE LINE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 7833831 ↗
• InjuryAug 30, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT CUT THE TISSUE. THE SURGEON STATED THAT WHEN THEY FIRED THE STAPLE THE KNIFE DID NOT CUT BUT STAPLES DID A COMPLETE STAPLE LINE. THEY STATED THAT THE BLADE ¿BOWED¿ OUT FROM THE SHAFT FROM THE REUSABLE STAPLER. THEY STATED THIS HAPPENED WITH TWO DIFFERENT LOADS. THEY MANUALLY CUT BETWEEN THE STAPLES AND OVER SOWED THE STAPLE LINE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 7833579 ↗
• InjuryAug 30, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT CUT THE TISSUE. THE SURGEON STATED THAT WHEN THEY FIRED THE STAPLE THE KNIFE DID NOT CUT BUT STAPLES DID A COMPLETE STAPLE LINE. THEY STATED THAT THE BLADE ¿BOWED¿ OUT FROM THE SHAFT FROM THERE USABLE STAPLER. THEY STATED THIS HAPPENED WITH TWO DIFFERENT LOADS. THEY MANUALLY CUT BETWEEN THE STAPLES AND OVER SOWED THE STAPLE LINE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 7833067 ↗
• InjuryAug 30, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT CUT THE TISSUE. THE SURGEON STATED THAT WHEN THEY FIRED THE STAPLE THE KNIFE DID NOT CUT BUT STAPLES DID A COMPLETE STAPLE LINE. THEY STATED THAT THE BLADE ¿BOWED¿ OUT FROM THE SHAFT FROM THE REUSABLE STAPLER. THEY STATED THIS HAPPENED WITH TWO DIFFERENT LOADS. THEY MANUALLY CUT BETWEEN THE STAPLES AND OVER SOWED THE STAPLE LINE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 7832456 ↗
• InjuryAug 8, 2018Misfire; Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, ON ANASTOMOSES, THE DEVICE PARTIALLY FIRED AND THERE WAS AN INCOMPLETE STAPLE LINE. THEY MANUALLY OVER SEWED USING A TRADITIONAL SUTURES TO FIX THE STAPLE LINE. THE SURGICAL TIME WAS EXTENDED BY 1-2 HOURS.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7762810 ↗
• MalfunctionMar 7, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING SUB TOTAL GASTRECTOMY, THEY OPENED THE PACKAGE AND TRIED TO CONNECT CARTRIDGE TO DEVICE, HOWEVER THEY NOTICED THE STAPLES OF THE PROXIMAL END CAME OUT OF THE STAPLE POCKETS. THEY STOPPED USING THIS CARTRIDGE AND REPLACED BY THE NEW CARTRIDGE, NOW THE FIRING IS COMPLETE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. PATIENT THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7322061 ↗
• MalfunctionMar 2, 2018Failure to Form Staple; Appropriate Device Problem Term/Code Not Available; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER: FOR THE SECOND FIRING OF THE FUNCTIONAL END-TO-END ANASTOMOSIS IN LAPAROSCOPIC RIGHT HEMI-COLECTOMY, THE SURGEON STARTED THE FIRING AT THE CLOSURE OF INSERTION ,HOWEVER THE PLASTIC KNOB BECAME STIFF BEFORE REACHING AT THE STAPLE LINE OF FUNCTIONAL END-TO-END ANASTOMOSIS. THE SURGEON CONTINUED THE FIRING AND SAPLING, HOWEVER THE KNIFE WAS STOPPED ON THE HALFWAY. REPLACED BY A NEW CARTRIDGE, THE ADDITIONAL TISSUE RESECTION WITH A NEW STAPLE LINE WAS COMPLETED WITH NO PROBLEM. THE STATUS OF THE PATIENT IS ALIVE WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311023 ↗
• MalfunctionJan 10, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER: OCCURRED DURING A COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS PROCEDURE. FOR THE FIRST FIRING, THE SURGEON TRIED TO PUSH THE PLASTIC KNOB. HOWEVER, COULD NOT PUSH IT AND COULD NOT FIRE THE DEVICE. REPLACED BY A NEW CARTRIDGE, HOWEVER, THE FIRING STOPPED ON THE HALFWAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7178684 ↗
• MalfunctionJan 10, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER: OCCURRED DURING A COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS PROCEDURE. FOR THE FIRST FIRING, THE SURGEON TRIED TO PUSH THE PLASTIC KNOB. HOWEVER, COULD NOT PUSH IT AND COULD NOT FIRE THE DEVICE. REPLACED BY A NEW CARTRIDGE, HOWEVER, THE FIRING STOPPED ON THE HALFWAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7178677 ↗
• MalfunctionDec 11, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER: OCCURRED DURING A PROXIMAL PANCREATICDUODENECTOMY PROCEDURE. FOR THE FIRST FIRING, THE SURGEON TRIED TO FIRE THE DEVICE TO THE STOMACH, HOWEVER, COULD NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7104197 ↗
• MalfunctionDec 7, 2017Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, THE SURGEON FIRED THE DEVICE, THE KNIFE WAS ADVANCED AND THE TISSUE WAS FULLY RESECTED ,HOWEVER THE STAPLING WAS INCOMPLETE. THE STAPLES WERE MALFORMED IN U-FORMED OR M-FORMED. AS THE CUT END WERE UNSTAPLED ,THE SURGEON MANUALLY SUTURED THE INCOMPLETE STAPLE LINE. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES AND OOZING BLEEDING OCCURRED AS A RESULT. NO INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7094978 ↗
• MalfunctionNov 16, 2017Misfire; Misfire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING FOR PROXIMAL PANCREATICODUODENECTOMY, THE SURGEON STARTED FIRING THE DEVICE, HOWEVER COULD NOT ADVANCE THE FIRING KNOB ON THE HALFWAY. REPLACED BY NEW CARTRIDGE AND STARTED FIRING, HOWEVER THE SAME EVENT OCCURRED ON THE HALFWAY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7039047 ↗
• MalfunctionNov 16, 2017Misfire; Misfire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING FOR PROXIMAL PANCREATICODUODENECTOMY, THE SURGEON STARTED FIRING THE DEVICE, HOWEVER COULD NOT ADVANCE THE FIRING KNOB ON THE HALFWAY. REPLACED BY NEW CARTRIDGE AND STARTED FIRING, HOWEVER THE SAME EVENT OCCURRED ON THE HALFWAY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7039045 ↗
• MalfunctionOct 16, 2017Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN INTRAPELVIC TUMOR RESECTION (SARCOMA) PROCEDURE, 9 OF 10 FIRINGS FOR INTRAPELVIC TUMOR RESECTION (SARCOMA) WERE SUCCESSFUL. AT THE SECOND FIRING IN QUESTION, FOR SMALL INTESTINE RESECTION, THE SURGEON FIRED THE DEVICE AND THE KNIFE RESECTED THE TISSUE, HOWEVER NO STAPLE WAS FIRED ON IT. NO STAPLE FELL INTO THE CAVITY, EITHER. THEN THE SURGEON CLAMPED THE CUT END OF SMALL INTESTINE WITH FORCEPS AND SUTURED IT MANUALLY. OOZING BLEEDING OCCURRED AS A RESULT OF THE ISSUE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6951232 ↗