Signia SIGCIRXLRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521845497), received between Mar 5, 2026 and Sep 23, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that during a robotic-assisted left colectomy, the device was fired and the screen showed the anvil was tilting before removal. After removal, the device was examined and the reload had become detached from the adapter. The reload came off as the integrated trocar extended and prevented the anvil from tilting. After troubleshooting, the reload was able to be returned to the adapter and allowed the anvil to tilt normally. No patient harm or complications. After the case, the adapter and handle were tested with a fresh reload without any issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863531 ↗
• MalfunctionSep 22, 2026Device Slipped; Device Displays Incorrect Message

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860374 ↗
• MalfunctionSep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose

  MAUDE report 50854766 ↗
• MalfunctionJul 2, 2026Device Slipped; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED LOW ANTERIOR RESECTION, THE POWERED CIRCULAR STAPLER DISPLAYED ALL GREEN INDICATORS DURING ASSEMBLY. THE DEVICE WAS INSERTED, THE SPIKE WAS EXTENDED TO THE MAXIMUM POSITION, AND THE ANVIL WAS CONNECTED WITHOUT ISSUE. WHEN THE FIRST ASSISTANT ATTEMPTED TO CLOSE THE DEVICE TO APPLY IT TO THE VERY LOW RECTUM, IT DID NOT FULLY CLOSE, AND A YELLOW ADAPTER GENERAL ERROR CODE APPEARED ON THE SCREEN. THE TEAM ATTEMPTED TO OPEN AND CLOSE THE DEVICE THREE ADDITIONAL TIMES; HOWEVER, THE ISSUE PERSISTED. THE SURGEON THEN REMOVED THE CIRCULAR STAPLER AND REPLACED IT WITH A MANUAL CIRCULAR STAPLER, WHICH WAS FIRED WITHOUT ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688906 ↗
• MalfunctionApr 28, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE STAPLER WAS STUCK ON THE HOME SCREEN EVEN AFTER CONNECTING THE ANVIL AND APPROXIMATING THE ANVIL TO THE RELOAD. THE STAPLER WOULD NOT BEGIN THE PERCENTAGE PORTION OF THE DEVICE. THE USER RE-EXTENDED THE SPIKE TO 100% AND THIS ISSUE DID NOT PERSIST. AFTER FIRING THOUGH, THERE WAS NO ISSUE WITH THE STAPLE LINE, YET THERE WAS A TEAR IN THE BOWEL WHICH WAS NOTICED DURING LEAK TEST. STAPLE LINE WAS OVERSEWN. SURGICAL TIME WAS EXTENDED AS A RESULT OF THIS EVENT. THE BOWEL TEAR WAS NOT RELATED TO THE DEVICE.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 25013207 ↗
• MalfunctionApr 17, 2026Difficult to Remove; Failure to Cut; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC SIGMOID COLECTOMY TO CREATE AN ANASTOMOSIS IN THE DISTAL COLON, WHEN CLOSING THE ANVIL, THE EXCESSIVE FORCE ICON APPEARED. IT WAS NOTED THAT THE ICON WAS INTENTIONAL, TO WAIT SEVERAL SECONDS FOR ANVIL TO CONTINUETO CLOSE AND REACH 100% CLOSED. ONCE THE FIRING BUTTON ILLUMINATED, THE PHYSICIAN PROCEEDED TO FIRE AS USUAL. THE STAPLE ICON ILLUMINATED AS USUAL, AND THE KNIFE CUTTING GRAPHIC ILLUMINATED AS USUAL, BUT THEN SHOWED A SPIKE ERROR GRAPHIC FOR 1 SECOND WHICH WAS A RED CIRCLE WITH LINE THAT APPEARED ON THE KNIFE BLADE. THE NORMAL ICON APPEARED INSTRUCTING USER TO PRESS UP BUTTON TO OPEN ANVIL. AS PHYSICIAN WENT TO OPEN ANVIL, THE RELOAD YELLOW SWIM LANE ERROR APPEARED. THE ANVIL DID OPEN AS USUAL, BUT THE STAPLER WAS EXTREMELY DIFFICULT TO REMOVE FROM THE ANASTOMOSIS. THE PHYSICIAN NOTED IT FELT AS THOUGH THE STAPLER DID NOT CUT ALL THE WAY. AFTER 2-3 MINUTES, THE PHYSICIAN WAS ABLE TO WIGGLE THE STAPLER OUT OF THE ANASTOMOSIS AND PATIENT'S BODY, BUT UPON SCOPING, 1/4 OF THE ANASTOMOSIS LOOKED LOOSE. IT WAS NOTED THAT THE PROCEDURE WAS EXTENDED BY 10 MINUTES. THE SURGEON SUTURED OVER THE ANASTOMOSIS AND PROCEEDED WITH THE CASE

  Patient problems: Failure to Anastomose

  MAUDE report 24915815 ↗
• MalfunctionMar 26, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING AN OPEN COLOSTOMY TAKEDOWN, WHILE ON RECTAL END-TO-END ANASTOMOSIS STEP, THE STAPLER WAS REPORTED TO BE DIFFICULT TO REMOVE FROM THE CAVITY, WHICH EXTENDED THE SURGICAL TIME BY 60 MINUTES. THE SURGEON INSTRUCTED A FELLOW TO REMOVE THE STAPLER FOLLOWING STANDARD PROTOCOLS. RESECTION AND RE-STAPLING WERE PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24706038 ↗
• MalfunctionMar 19, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC SIGMOID COLECTOMY, WHEN THE DEVICE WAS USED FOR AN END-TO-END ANASTOMOSIS, THE STAPLER LOCKED ON TISSUE AND WOULD NOT OPEN, REMAINING STUCK IN THE PATIENT. A YELLOW SWIMLANE ERROR APPEARED RELATED TO THE RELOAD. THE STAPLER DID NOT COMPLETE THE FIRING SEQUENCE AS EXPECTED, AND THE ANVIL/SPIKE DID NOT OPEN AFTER FIRING, REQUIRING MANUAL INTERVENTION. REMOVAL OF THE DEVICE FROM THE ANASTOMOSIS WAS DIFFICULT AND TOOK APPROXIMATELY 2-3 MINUTES TO REMOVE FROM THE COLON. TROUBLESHOOTING STEPS INCLUDED DETACHING AND REATTACHING THE STAPLER FROM THE ADAPTER, RESETTING THE STAPLER BY PRESSING TWO FIRE BUTTONS SIMULTANEOUSLY, ATTEMPTING TO RESET THE SPIKE BY PRESSING FOUR ROTATION BUTTONS SIMULTANEOUSLY, AND ULTIMATELY USING A MANUAL RETRACTION TOOL TO MANUALLY OPEN THE ANVIL. UPON VISUAL INSPECTION WITH A SCOPE, A SINGULAR UNFORMED STAPLE WAS OBSERVED AT THE ANASTOMOSIS, ALTHOUGH THE DONUTS WERE INTACT AND THE ANASTOMOSIS APPEARED COMPLETE OTHERWISE. A LEAK TEST WAS CONDUCTED AND SHOWED NO BUBBLES, CONFIRMING THE INTEGRITY OF THE ANASTOMOSIS. THE PROCEDURE WAS EXTENDED BY 20 MINUTES DUE TO DEVICE ISSUES.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637487 ↗
• MalfunctionMar 10, 2026Device Displays Incorrect Message; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC SIGMOIDECTOMY, AFTER THE POWERED CIRCULAR STAPLER COMPLETED ITS STAPLING AND FOLLOWING FIRING SEQUENCE AND BEFORE TAPPING UP ON THE TOGGLE, YELLOW SWIM LANES TWO FOR ADAPTER AND THREE FOR RELOAD TURNED YELLOW WITH A WARNING TRIANGLE. THE STAPLER PROMPTED THE SURGEON TO OPEN THE SPIKE, AND NOTHING HAPPENED, BUT THE SPIKE WAS FULLY EXTENDED. THE SURGEON EXTENDED THE SPIKE AND THE MIDDLE YELLOW SWIMLANE TURNED GREEN BUT THE LAST YELLOW SWIM LANE REMAINED YELLOW. THE SURGEON PROCEEDED TO PULL THE STAPLER OUT, AND IT CAME OUT WITHOUT THE ANVIL CONNECTED TO THE SPIKE. THE SURGEON HAD TO MANUALLY PULL THE ANVIL FROM THE PATIENT'S RECTUM. UPON INSPECTION, DONUTS WERE COMPLETE, AND THE LEAK TEST WAS NEGATIVE. THE SURGICAL TIME WAS EXTENDED BY 25 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558163 ↗
• MalfunctionMar 5, 2026Device Displays Incorrect Message; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC SIGMOID COLON PROCEDURE, THE DEVICE WAS APPEARING TO FIRE BUT DID NOT CUT, A YELLOW INDICATOR FOR BOTH THE ADAPTER AND RELOAD WAS SHOWN. THE DEVICE ATTEMPTED TO OPEN OR ADVANCE THE TILT TOP ANVIL BUT DID NOT, AND THE SCREEN REMAINED YELLOW ON THE RELOAD LANE DURING THE SIGMOID CIRCULAR STAPLING STEP. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 45 MINUTES. A NEW ANASTOMOSIS WAS CREATED AND A MANUAL CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24521006 ↗