Signia SIGPHANDLE-RFBRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521797437), received between Nov 7, 2021 and Sep 30, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Display/Image; Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952505 ↗
• MalfunctionApr 28, 2026Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch

  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. THE SURGERY WAS MODIFIED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 25012613 ↗
• MalfunctionApr 17, 2026Difficult to Remove; Failure to Cut; Device Displays Incorrect Message; Patient-Device Incompatibility; Insufficient Device Problem Information

  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 24915832 ↗
• 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 24521054 ↗
• MalfunctionOct 17, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING ROUX-EN-Y GASTRIC BYPASS, THE POWERED HANDLE WAS UNABLE TO FIRE. THE DEVICE DID NOT FIRE AFTER ATTEMPTS TO CHANGE THE RELOAD AND ADAPTER, AND REMAINED NONFUNCTIONAL FOLLOWING A HARD RESET. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323182 ↗
• MalfunctionSep 18, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CARDIAC GASTRECTOMY, THERE WAS EXCESSIVE FORCE ZONE LIMIT AT TIME OF FIRING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081376 ↗
• MalfunctionMay 15, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THERE WERE FIRING ISSUES WITH THE DEVICE DURING THE STAPLING OF THE STOMACH. THE RELOAD FIRED HALFWAY AND THEN RETRACTED BACK. TO RESOLVE THE ISSUE, THE RELOAD AND HANDLE WERE REPLACED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031587 ↗
• MalfunctionFeb 27, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE JAWS OF THE FOUR RELOADS WERE PINCHED SHUT TO ALLOW THE RELOADS TO FIT INTO THE 12 MILLIMETER TROCAR. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18792008 ↗
• MalfunctionJan 10, 2024Computer Software Problem; Device Displays Incorrect Message; Computer Software Problem; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING TESTING/MAINTENANCE, THERE WAS POWER HANDLE ERROR.  THE REBOOT FAILED AND HANDLE WOULD NOT TURN ON. CHARGER BAY, PORTS, CABLES ALL WORK WELL AND NO ISSUES CHARGING THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT ANALYSIS OF DATA STORED ON THE HANDLE SHOWS EVIDENCE OF FIELD PROGRAMMABLE GATE ARRAY (FPGA) RESET/REPROGRAM FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489394 ↗
• MalfunctionDec 14, 2023Unintended System Motion; Unintended System Motion

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BEFORE USING ON THE PATIENT, THE ADAPTER WOULD ARTICULATE ON ITS OWN. A NEW ADAPTER, SHELL AND HANDLE WERE USED TO RESOLVE THE ISSUE. THE ORIGINAL RELOAD WORKED FINE WITH THE NEW ADAPTER WAS NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332054 ↗
• MalfunctionAug 22, 2023Misfire; Device Displays Incorrect Message; Misfire; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING THE VIDEO ASSISTED THORACOSCOPY SURGERY WEDGECTOMY, WHILE ATTEMPTING TO STAPLE AROUND TUMOR LUNG TISSUE, THE 30 MILLIMETER PURPLE RELOAD FIRED CORRECTLY. THE SECOND FIRING WITH POWER HANDLE WAS 45 MILLIMETER BLACK RELOAD, DURING THIS FIRING, THE FIRING WAS ABLE TO BE COMPLETED BUT THE SURGEON DESCRIBE THE RELOAD AS PUSHING BACK ON THE TISSUE OR NOT FULLY STAPLING AND CUTTING THE TISSUE AS FAR AS EXPECTED BASED ON INITIAL POSITIONING OF THE RELOAD. ON THE THIRD 45 MILLIMETER RELOAD FIRING, THE ISSUE OCCURRED AGAIN WITH FULL FIRING OF THE RELOAD BUT NO ADVANCEMENT OF THE TISSUE TRANSECTION OCCURRED. THERE WERE MORE STAPLES BUILT UP ON THE TISSUE WITH LITTLE TO NO ADVANCEMENT OF THE STAPLE CUT LINE. DURING THE FOURTH FIRING OF ANOTHER 45 MILLIMETER BLACK RELOAD, THE POWER HANDLE SCREEN SHOWED THE EXCESSIVE THICKNESS AFTER FIRING TO THE CENTRAL PORTION OF THE STAPLE LINE. THE SURGEON WAITED TO ALLOW THE TISSUE MORE TIME TO COMPRESS AND FIRED FURTHER ANOTHER 1-2 MM AND THE EXCESSIVE ICON STOPPED THE STAPLER AGAIN. THE POWER HANDLE WAS UNABLE TO ADVANCE ANY FURTHER SO THE STAPLER WAS REMOVED. DURING THE FIFTH FIRING OF ANOTHER 45MILLIMETER BLACK RELOAD,

  Patient problems: Insufficient Information

  MAUDE report 17596892 ↗
• MalfunctionFeb 2, 2023Misfire; Device Displays Incorrect Message; Misfire; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING STAPLING OF THE STOMACH, WHILE USING THE FIRST 60MM RELOAD, THE FIRING STOPPED AT 50% WITH A NOTIFICATION OF EXCESSIVE FORCE ON THE HANDLE. THE SURGEON PAUSED FOR A FEW SECONDS AND TRIED TO RESUME THE FIRING MULTIPLE TIMES WITH NO SUCCESS. THE RELOAD WAS RETRACTED AND REMOVED, AND A SECOND 60MM RELOAD WAS USED. THE SECOND RELOAD ALSO STOPPED WITH EXCESSIVE FORCE AND COULD NOT ADVANCE. A THIRD RELOAD WAS ATTEMPTED TO BE USED; HOWEVER, THE SAME EXCESSIVE FORCE ERROR OCCURRED. THE SURGEON DECIDED TO USE A NEW HANDLE, SHELL, ADAPTER AND A FOURTH 60MM RELOAD. AGAIN, THE RELOAD STOPPED AND DID NOT ADVANCE. AT THAT POINT, A MANUAL HANDLE WAS OPENED WITH A NEW RELOAD, AND THE SURGEON STAPLED MEDIAL TO THE PREVIOUS FIRING, AND WITH MUCH DIFFICULTY, AND SEVERAL CRUNCHES OF THE HANDLE; THE RELOAD WAS SUCCESSFULLY DEPLOYED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283289 ↗
• MalfunctionNov 7, 2021Entrapment of Device; Misfire; Device Displays Incorrect Message; Entrapment of Device; Misfire; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, IT WAS FOUND THAT THERE WAS FAILURE IN SHAPE OF THE STAPLE IN THE DOUBLE-STAPLING SITE, THE STAPLING STOPPED AND COULD NOT BE ADVANCED. THE JAWS OF THE DEVICE LOCKED ON TISSUE, THE DISPLAY OF EXCESSIVE FORCE WAS INDICATED TEMPORARILY AND THE FIRING STOPPED, BUT WHEN THE FIRING WAS PERFORMED AGAIN, IT ADVANCED A LITTLE AND STOPPED AGAIN. AT THAT TIME, EXCESSIVE FORCE INDICATION WAS NOT DISPLAYED. TOTAL OF FIVE FIRINGS AT THE 2ND TO 6TH FIRING , THE STAPLING STOPPED MIDWAY, BUT ON AND AFTER THE 7TH FIRING, THE STAPLING BECAME POSSIBLE AS USUAL. THE JAWS WERE OPENED IN THE MIDDLE OF STAPLING AND REPLACED WITH ANOTHER CARTRIDGE AND THE HANDLE WAS ALSO REPLACED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756318 ↗