Premium Plus CEEA 111985Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10884523006599), received between Aug 16, 2017 and Nov 5, 2024 — classified as 44 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (38 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, DURING RECTAL ANASTOMOSIS, WHEN FIRING, THE SURGEON FELT AS IF THE DEVICE WAS DISLODGED DURING NEEDLE INSERTION. GIVING THE IMPRESSION THAT IT HAS NOT BEEN FIRED FIRMLY. THE WING NUT WAS TURNED TWICE TO TILT THE ANVIL, BUT SINCE IT WAS TURNED MORE THAN TWO TIMES, THE ANVIL CAME OFF WHEN THE ANASTOMOSIS DEVICE WAS REMOVED. THE DONUT RING WAS CONFIRMED TO BE COMPLETE SO THE OPERATION WAS COMPLETED WITH THE SAME STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610593 ↗
• MalfunctionMay 9, 2024Loss of or Failure to Bond; Material Twisted/Bent; Positioning Problem; Loss of or Failure to Bond; Material Twisted/Bent; Positioning Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC TOTAL GASTRIC SURGERY, WHEN THE STOMACH AND DUODENUM WERE ANASTOMOSED, THE INSTRUMENT ROD WAS ON THE STOMACH SIDE AND THE ANVIL WAS ON THE DUODENUM. THE ANVIL WAS BENT BEFORE FIRING CAUSING THE INSTRUMENT FAILED TO DOCK. IT WAS NOTED THAT UNUSUAL EFFORT WAS REQUIRED TO TURN THE TWIST KNOB IN ORDER TO VISUALIZE THE GREEN BAR. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281718 ↗
• InjuryFeb 16, 2023Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC THORACOSCOPIC ESOPHAGECTOMY, WHEN THE STUMP OF THE ESOPHAGUS AND THE TUBULAR STOMACH WERE ANASTOMOSED, STAPLE LINE WAS INCOMPLETE AND THERE WAS NO TISSUE. TO RESOLVE THE ISSUE, RESECTION WAS PERFORMED AND ANOTHER STAPLER WAS USED TO RESTAPLE.

  Patient problems: Failure to Anastomose

  MAUDE report 16388178 ↗
• InjuryFeb 15, 2023Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING DISTAL GASTRECTOMY, THERE WAS AN INCOMPLETE STAPLE LINE AFTER DIGESTIVE TRACT RECONSTRUCTION AND THE STAPLES WERE NOT FULLY FORMED. IT WAS ALSO MENTIONED THAT THE ANVIL DID NOT TILT AFTER FIRING. THE SURGEON HAD TO PERFORMED EMBEDDING BY SEW OVER TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Failure to Anastomose

  MAUDE report 16383027 ↗
• InjuryDec 2, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, WHEN THE RELOAD WAS USED TO DISSECT THE RIGHT HEMICOLON THE STAPLE LINE WAS INCOMPLETE. WHEN PART OF THE INTESTINAL TUBE WAS REMOVED, A NEW RELOAD WAS USED AND THE FIRING WAS NORMAL. A CIRCULAR STAPLER WAS USED TO ANASTOMOSE THE BROKEN INTESTINAL TUBE, HOWEVER AFTER PRESSING THE GREEN BUTTON, THE CIRCULAR STAPLER DID NOT FIRE. A NEW CIRCULAR STAPLER WAS USED FOR ANASTOMOSIS AND COMPLETE THE PROCEDURE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15909814 ↗
• InjuryNov 1, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SUBTOTAL GASTRECTOMY, THE TWO NEW LINEAR RELOADS WERE USED TO AMPUTATE THE STOMACH. THERE WAS BAD B-SHAPE STAPLES NOTED. SUBSEQUENTLY, WHEN A CIRCULAR STAPLER WAS USED FOR GASTRO-JEJUNUM ANASTOMOSIS, THE INSTRUMENT HANDLE WAS SQUEEZED ENOUGH TO MAXIMIZE THE METAL UNDERSIDE OF THE HANDLE IN CONTACT WITH THE STAPLER BODY AND THE DEVICE WAS ABLE TO FIRE. THE CIRCULAR ANASTOMOSIS WAS COMPLETE BUT THERE WAS ALSO POOR B-SHAPE STAPLES. SUTURES WERE ADDED AFTERWARDS TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15708982 ↗
• MalfunctionOct 29, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN PANCREATODUODENECTOMY, WHEN DEVICE WAS USED FOR GASTROJEJUNOSTOMY, THE SPACE BETWEEN THE CARTRIDGE AND ANVIL CLOSED AND THE GREEN BAR WAS VISIBLE IN THE INDICATOR WINDOW BUT DEVICE DID NOT FIRE. SURGERY CONTINUED AFTER REPLACING THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694523 ↗
• InjuryOct 24, 2022Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SUBTOTAL GASTRECTOMY PROCEDURE, WHILE DETACHING THE STOMACH, THE FIRST RELOAD DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE EVEN WHEN THE GREEN BUTTON WAS PRESSED. A SECOND RELOAD WAS USED, BUT THE STAPLE LINE WAS DISTALLY INCOMPLETE. A THIRD RELOAD WAS USED TO RESOLVE THE ISSUE. WHILE PERFORMING GASTRO-JEJUNUM ANASTOMOSIS, THE CIRCULAR STAPLER HAD POOR STAPLE FORMATION. IT WAS ALSO NOTED THAT THE ANVIL DID NOT TILT AFTER FIRING. THE SURGEON USED SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15658738 ↗
• MalfunctionSep 30, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE ANVIL CANNOT BE ATTACHED WITH THE HANDLE. A NEW HANDLE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521254 ↗
• MalfunctionSep 30, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE ANVIL CANNOT BE ATTACHED WITH THE HANDLE. A NEW HANDLE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520923 ↗
• MalfunctionSep 30, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE ANVIL CANNOT BE ATTACHED WITH THE HANDLE. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520624 ↗
• MalfunctionSep 23, 2022Difficult to Remove; Device Damaged Prior to Use; Detachment of Device or Device Component; Difficult to Remove; Device Damaged Prior to Use; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, A COMPONENT OF THE DEVICE DISENGAGED. IT WAS ALSO NOTED THAT THE ANVIL DID NOT TILT AFTER FIRING. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15471823 ↗
• InjuryJun 30, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AT THE ANASTOMOSIS, THE DEVICE CUT BUT NO STAPLES DEPLOYED. A NEW DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14880569 ↗
• InjuryJun 28, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL RESECTION FOR RECTAL CANCER, WHILE ON ANASTOMOSIS, THERE WAS POOR STAPLE FORMATION. SOME STAPLES DID NOT CLOSE. THE STAPLE LINE WAS FIXED BY RESECTION AND RE-STAPLING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 14844154 ↗
• InjuryJun 27, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTAL GASTRECTOMY, WHEN THE DEVICE WAS USED FOR END-TO-END ANASTOMOSIS OF THE ESOPHAGUS-JEJUNUM, IT WAS OBSERVED THAT THERE WAS POOR STAPLE FORMATION. THE PART OF B-SHAPED STAPLE LINE WAS POORLY FORMED. SUBSEQUENT MEASURES WERE TAKEN TO OVER SEW THE STAPLE LINE TO FIX THE ISSUE. .

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14832738 ↗
• MalfunctionJun 24, 2022Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  ACCORDING TO THE REPORTER, ANTEGRADE TUBULAR GASTRIC SURGERY, WHEN USING THE STAPLER FOR ESOPHAGUS-TUBULAR GASTRIC ANASTOMOSIS, THE RESISTANCE WAS TOO LARGE AND DEVICE COULD NOT BE FIRED. THE ANVIL ALSO WOULD NOT TILT AFTERWARDS. THE ANASTOMOSIS COULD BE PERFORMED NORMALLY ONCE THE STAPLER WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806969 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED OUTCOMES OF PATIENTS WHO UNDERWENT SLEEVE GASTRECTOMY WITH GASTROILEOSTOMY ANASTOMOSIS USING A CIRCULAR STAPLED ANASTOMOSIS OR A LINEAR STAPLED ANASTOMOSIS BETWEEN JANUARY 2018 AND APRIL 2019. IN THE LINEAR STAPLED GROUP, A TRI-STAPLE STAPLER MAY HAVE BEEN USED TO CREATE THE SLEEVE, ILEAL TRANSECTION AND ANASTOMOSIS. IN THE CIRCULAR STAPLED GROUP, A LINEAR STAPLER WAS USED TO CREATE THE SLEEVE AND THE ILEAL TRANSECTION AND A CIRCULAR STAPLER WAS USED FOR THE ANASTOMOSIS. A SUTURE WAS USED TO CLOSE THE ENTEROTOMIES. THERE WERE 24 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED: 2 HEMORRHAGES IN THE LINEAR STAPLED GROUP AND 1 BLEEDING IN THE CIRCULAR STAPLED GROUP. NO INTERVENTIONS WERE SPECIFIED. COMPLICATIONS WERE NOT RELATED TO THE SUTURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14436016 ↗
• InjuryMar 29, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN RIGHT HEMICOLECTOMY PROCEDURE, IN THE PROCESS OF ANASTOMOSIS OF THE INTESTINE, IT WAS FOUND THAT THE STAPLES DID NOT FORM PROPERLY, AND THE ANASTOMOSIS WAS NOT FIRM. TO FIX THE STAPLE LINE IT WAS RESECTED AND RE-STAPLED. ANOTHER DEVICE WAS USED TO COMPLETE THE ANASTOMOSIS AND RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 13942717 ↗
• MalfunctionMar 10, 2022Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING A PALLIATIVE RESECTION FOR ESOPHAGEAL CANCER, THE DEVICE WAS DIFFICULT TO CLOSE. THE SHAFT COULD NOT BE PUSHED IN AFTER THE ANVIL WAS PLACED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13719898 ↗
• MalfunctionMar 3, 2022Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING ESOPHAGEAL AND GASTRIC ANASTOMOSIS, THE DEVICE WAS DIFFICULT OR UNABLE TO CLOSE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660748 ↗
• InjuryJan 25, 2022Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, THE DEVICE PARTIALLY FIRED AND HAD POOR STAPLE FORMATION. PART OF JEJUNUM WAS RESECTED AND NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13343093 ↗
• MalfunctionJan 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS OF STOMACH TO ESOPHAGUS IN AN OPEN ESOPHAGECTOMY, THE ANVIL CAME OFF AS THE DEVICE WAS BEING WITHDRAWN. THE SURGEON NEED TO MANUALLY "MILK" THE ANVIL THROUGH ANASTOMOSIS AND IS REMOVED WITH DIGITAL MANIPULATION TO THE OUTSIDE OF THE ESOPHAGUS AND GASTROTOMY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13322859 ↗
• MalfunctionJan 6, 2022Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL GASTRECTOMY, WHILE PERFORMING THE END-TO-SIDE ESOPHAGOJEJUNOSTOMY, THE DEVICE STAPLED COMPLETELY BUT THE BLADE DID NOT CUT. TO RESOLVE THE ISSUE, THE SURGEON DID A MANUAL RESECTION. THERE WAS A NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177658 ↗
• MalfunctionDec 2, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLON SURGERY, WHILE PERFORMING ANASTOMOSIS ON THE TISSUE, THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE AND FIRE THE DEVICE. THE SURGEON USED A NEW DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920234 ↗
• InjuryNov 19, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PARTIAL GASTRECTOMY, THE STAPLE WAS FOUND TO BE FORMED POORLY WHEN IT WAS FIRED. IT WAS ALSO NOTED THAT THE DONUT IS INCOMPLETE. TO RESOLVE THE ISSUE,  THE STAPLE LINE WAS OVER SEWED. A NEW DEVICE WAS USED AS WELL.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12846722 ↗