Premium Plus CEEA 111981Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884523006575), received between Apr 3, 2017 and Dec 28, 2023 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL COLECTOMY, THE STAPLER DID NOT FIRE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18411939 ↗
• InjuryNov 6, 2020Difficult 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, WHILE PERFORMING ANASTOMOSIS BETWEEN RECTUM AND PROXIMAL SIGMA IN A RECTAL CANCER RESECTION, SOME STAPLES WERE NOT FORMING PROPER B SHAPE. IT WAS NOTED THAT IT WAS DIFFICULTY REMOVING STAPLER FROM CAVITY. STAPLER WAS REMOVED BY ROTATING THE STAPLER AND WITH USING FORCE. AS A RESULT, WAS GETTING POSITIVE BUBBLE TEST AND AFTER DETAILED INSPECTION OF ANASTOMOSIS WAS VISUALIZED TISSUE TEARING. A PART OF BOWEL WITH THIS ANASTOMOSIS WAS REMOVED AND PERFORMED SECOND ANASTOMOSIS. SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE DEVICE ISSUE.

  Patient problems: Failure to Anastomose; No Code Available; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10803648 ↗
• InjuryJul 29, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING CREATION OF ANASTOMOSES ON ROBOTIC LAPAROSCOPIC LOW ANTERIOR RESECTION, THE WING NUT WAS STUCK AND DID NOT COMPLETE THE TURN WHEN OPENING AND THE ANVIL DID NOT FULLY TILT. THE TISSUE WAS CUT POORLY, AND THE DEVICE WAS UNABLE TO BE OPENED AND REMOVE FROM TISSUE. THE SURGEON HAD TO CUT OUT THE TISSUE AND THE DEVICE WAS REMOVED. THIS RESULTED TO TISSUE DAMAGED AND ANASTOMOSIS HAD TO BE RE-OPERATED. THE EVENT LED TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES AND EXTEND PATIENT HOSPITALIZATION FOR MORE THAN ONE WEEK.

  Patient problems: Failure to Anastomose; No Code Available; Tissue Damage

  MAUDE report 8839750 ↗
• MalfunctionJun 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN LOW ANTERIOR RESECTION PROCEDURE, COMPONENT DISENGAGED AT THE BOTTOM OF ANVIL AND BODY PART OF CIRCULAR STAPLE. SURGEON CONTINUED THE PROCEDURE WITH NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8742549 ↗
• InjuryJun 20, 2019Failure to Cut; Human-Device Interface Problem; Failure to Cut; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC COLORECTAL SURGERY, DURING THE LAST STEP WHERE ANASTOMOSIS FROM SIDE TO END WAS BEING PERFORMED, THE DEVICE STAPLED BUT DID NOT CUT THE TISSUE. THE ANVIL OF THE DEVICE THEN COULD NOT BE REMOVED FROM THE TISSUE. IT WAS STATED THAT THE DEVICE WAS APPLIED OVER A PREVIOUS STAPLE LINE. THE COLON HAD TO BE INTERRUPTED ABOVE AND BELOW IN ORDER TO REMOVE THE ANVIL. MORE COLON WAS TAKEN FROM THE PATIENT AS THE SURGEON HAD TO REMOVE THE PART OF THE DAMAGED INTESTINE AND CREATE A NEW ANASTOMOSIS USING ANOTHER DEVICE. THE INCISION WAS EXTENDED FOR MORE THAN 1 INCH. IT WAS ALSO STATED THAT THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED FOR ONE WEEK.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8717305 ↗
• MalfunctionMar 12, 2018Difficult to Open or Close; Positioning Problem; Difficult to Open or Close; Positioning Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE OF LOW ANTERIOR RESECTION, THE DEVICE WAS DIFFICULT OR UNABLE TO CLOSE. UNUSUAL EFFORT WAS NEEDED TO TURN THE TWIST KNOB IN ORDER TO VISUALIZE THE GREEN BAR. THE PATIENT HAD NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7332716 ↗
• InjuryApr 3, 2017Difficult to Remove; Misfire; Difficult to Remove; Misfire

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN SIGMOIDECTOMY PROCEDURE WITH DST ANASTOMOSIS. WHEN THE SURGEON TRIED TO PULL THE DEVICE OUT AFTER FIRING IT, THE ANVIL CAUGHT UP AND THE DEVICE COULD NOT BE REMOVED FROM THE STAPLING SITE. THE SURGEON PULLED IT SEVERAL TIMES, THE DEVICE GOT OUT BUT THE ANVIL REMAINED IN THE INTESTINAL TRACT. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE WAS CAUSED. THE SURGEON ATTEMPTED TO PULL OUT THE ANVIL BUT COULD NOT WITHDRAW IT. RESECTED THE MOUTH SIDE AND THENAL SIDE TISSUE ADDITIONALLY AND PERFORMED ANASTOMOSIS AGAIN USED A NEW PRODUCT. ADDITIONAL TISSUE RESECTION WAS REQUIRED DUE TO THE TISSUE. THERE WAS TISSUE DAMAGE. WHEN EXAMINING THE SPECIMENS THAT WERE TAKEN OUT, THE TISSUE WAS CUT FOR TWO-THIRDS, BUT ONE-THIRD WAS UNCUT. THE SURGICAL TIME WAS EXTENDED BY LESS THAN THIRTY MINUTES. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: Injury; Tissue Damage

  MAUDE report 6452869 ↗