Premium Plus CEEA 111983Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884523006582), received between Mar 23, 2017 and Mar 31, 2023 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SIGMOIDECTOMY, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659917 ↗
• MalfunctionNov 2, 2022Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC GASTRECTOMY, WHEN THE DEVICE WAS USED TO PERFORM ESOPHAGUS AND JEJUNUM ANASTOMOSIS, THE SURGEON FOUND THAT THE STAPLE WAS STUCK AND THE STAPLER COULD NOT BE FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716371 ↗
• InjurySep 20, 2022Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON AN ESOPHAGOGASTROSTOMY, WHEN USING THE END-TO-END STAPLER TO PERFORM RADICAL RESECTION OF ESOPHAGEAL CANCER, THERE WAS POOR CUTTING AND ANASTOMOTIC OBSTACLE. SUTURE REINFORCEMENT WAS GIVEN AROUND THE ANASTOMOSIS.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15457554 ↗
• MalfunctionAug 12, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ESOPHAGEAL STOMACH ANASTOMOSIS, THE DEVICE PARTIALLY FIRED.

  Patient problems: Insufficient Information

  MAUDE report 15222376 ↗
• InjuryJan 25, 2022Difficult to Remove; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL ESOPHAGECTOMY PROCEDURE, WHILE THE ESOPHAGUS WAS BEING ANASTOMOSED, THE STAPLES DID NOT FORM PROPERLY AND THERE WAS AN ANASTOMOTIC BLEEDING. THE ANVIL DOES NOT TILT AFTER FIRING. SUTURE REINFORCEMENT WAS DONE TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 13342646 ↗
• InjuryNov 22, 2019Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER DID NOT FULLY CUT. THE STAPLER WAS THEN REPLACED.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9364669 ↗
• MalfunctionNov 8, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED ON STOMACH CANCER DURING ENDOSCOPIC SUBTOTAL GASTRECTOMY, THE DEVICE COULD NOT BE FIRED. A NEW DEVICE WAS REPLACED FOR ANASTOMOSIS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9298143 ↗
• InjuryOct 31, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL GASTRECTOMY PROCEDURE, AFTER THE ANASTOMOSIS, THE ANVIL GOT STUCK TO THE ANASTOMOSED SITE AND THE SURGEON TRIED TO PULL AND PUSH IT BUT IT WAS DIFFICULT TO REMOVE SO ADDITIONAL FORCE WAS USED AND THE HEAD CAME OFF. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE CAUSING TISSUE DAMAGED. THE SURGICAL PROCEDURE WAS EXTENDED FOR LESS THAN 30 MINUTES. THE ISSUE WAS RESOLVED BY MANUAL SUTURING.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9261462 ↗
• MalfunctionOct 2, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS UNABLE TO FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145171 ↗
• MalfunctionDec 5, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING AN ESOPHAGECTOMY PROCEDURE, THE DEVICE PROPERLY LOADED BUT THE ANVIL FELL OFF THE DEVICE AND FELL INTO THE PATIENT'S CAVITY. THE ANVIL HAD TO BE CUT OUT TO BE REMOVED AND RETRIEVED. NO TISSUE DAMAGE. THEY OPENED ANOTHER CIRCULAR STAPLER AND COMPLETED THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7084126 ↗
• MalfunctionSep 15, 2017Misfire; Failure to Form Staple; Difficult to Open or Close; Misfire; Failure to Form Staple; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A RADICAL RESECTION OF COLON PROCEDURE, THE DEVICE JAWS WERE DIFFICULT OR UNABLE TO OPEN. THERE WAS POOR STAPLE FORMATION AND THE STAPLE LINE WAS INCOMPLETE - THEY OVERSEWED THE STAPLE LINE. ALSO THE DONUT WAS NOT COMPLETE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6869716 ↗
• InjuryMar 23, 2017Entrapment of Device; Failure to Form Staple; Entrapment of Device; Failure to Form Staple

  ACCORDING TO THE REPORTER; DURING AN ESOPHAGECTOMY PROCEDURE, AFTER THE DOCTOR FIRED THE DEVICE TO ANASTOMOSE THE ESOPHAGUS AND GASTRIC TUBE, THE DOCTOR REMOVE THE DEVICE FROM THE TISSUE MUCH DIFFICULTY. HE FOUND ONE HOLE NEAR THE PART OF ANASTOMOSIS. THE DOCTOR SUTURED TO COMPLETE THE SURGERY. THERE WAS NO ISSUE WITH THE PATIENT AFTER THE CASE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENSION OF SURGICAL TIME BY 30MIN OR MORE. CURRENT PATIENT STATUS IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6427197 ↗