Signia SIGSBCHGRRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884521543867), received between Sep 25, 2017 and Jan 20, 2025 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (30 reports).

14 other recalls cover devices cleared under the same FDA submission (K160176, K201672); they may or may not involve this specific model.

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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2025Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED THAT DURING USE, A FIRE OCCURRED POTENTIALLY INVOLVING THE SIGNIA DEVICE AS THE SOURCE, CAUSING DAMAGE BOTH TO THE SIGNIA POWER HANDLE AND CHARGER. TO RESOLVE THE ISSUE, THE PRODUCTS WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193031 ↗
• MalfunctionDec 19, 2022Failure to Charge; Adverse Event Without Identified Device or Use Problem; Failure to Charge; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE SURGERY OF THE CANCER AT ESOPHAGUS AND STOMACH JUNCTION, HANDLE'S INSUFFICIENT CHARGE WAS DETECTED. THE HANDLE WAS CHARGED BUT THE CHARGING WAS NOT PROGRESSING AT ALL DESPITE THE BATTERY CHARGER LIT GREEN. A DIFFERENT PROCEDURE WAS PERFORMED ON THE SAME PATIENT FOR ABOUT 2 HOURS UNTIL THE BATTERY COULD BE CHARGED, WHICH CAUSED INCONVENIENCE TO THE PROGRESS OF THE OPERATION. THE HANDLE WAS ABLE TO CHARGE USING ANOTHER CHARGER IN THE HOSPITAL. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16011171 ↗
• MalfunctionNov 9, 2021Failure to Charge; Corroded; Melted; Product Quality Problem; Failure to Charge; Corroded; Melted; Product Quality Problem

  ACCORDING TO THE REPORTER, THE GREEN LAMP DID NOT ILLUMINATE EVEN WHEN CHARGING THE DEVICE. THE PINS OF BOTH THE HANDLE AND CHARGER SEEMS TO BE MELTED. ANOTHER HANDLE WAS CONNECTED TO THE CHARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780336 ↗
• MalfunctionOct 20, 2021Melted; Overheating of Device; Product Quality Problem; Melted; Overheating of Device; Product Quality Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE METAL PART FROM THE CHARGER MELTED WHEN THE HANDLE WAS REMOVED. THE HANDLE WAS THEN CHARGED USING ANOTHER CHARGER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666676 ↗
• MalfunctionJul 18, 2021Sparking; Sparking

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, A TRACE WHICH MIGHT BE SPARK WAS FOUND ON THE CHARGER. THE HANDLE AND CHARGER WERE WIPED DOWN WITH GAUZE, BUT DID NOT FIND ANY DIRT WHICH CAN BE OCCURRED FROM FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186736 ↗
• MalfunctionJul 1, 2021Failure to Charge; Power Problem; Failure to Charge; Power Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BATTERY CHARGER WAS FLASHING RED, AND THE HANDLE DID NOT WORK. IT WAS BLACKOUT, AND THERE WAS NO OPERATING TONE. ANOTHER DEVICE WAS USED INSTEAD. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION BASED ON THE EVIDENCE AVAILABLE THE REPORTED CONDITION OF THE HANDLE NOT WORKING AFTER BEING REMOVED FROM THE CHARGER WAS CONFIRMED. THE CELL VENTING IS AN INTEGRATED DESIGN FEATURE OF THE CELL THAT PRODUCES A DISCHARGE OF THE ELECTROLYTE FLUID AND RENDERS THE BATTERY CELL NONFUNCTIONAL AND NON-CHARGEABLE WHEN BATTERY CELL LIFE HAS BEEN EXCEEDED. ROOT CAUSE OF THE OBSERVED VENTED BATTERY WAS DETERMINED TO BE FROM BATTERY DEGRADATION. DEVICE BATTERY MANAGEMENT ENHANCEMENTS ARE BEING EVALUATED TO EXTEND BATTERY LIFE AND ENHANCE BATTERY HEALTH MONITORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099320 ↗
• MalfunctionDec 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE HANDLE WAS NOT CHARGING. THERE WAS NO GREEN LIGHT FROM CHARGER EVEN IF THE HANDLE WAS SEATED PROPERLY. THE SURGEON USED MANUAL STAPLER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11018988 ↗
• MalfunctionAug 6, 2020Failure to Charge; Melted; Failure to Charge; Melted

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UPON INSERTING THE HANDLE, LIGHT-EMITTING DIODE (LED) FLASHED GREEN AT THE BEGINNING INDICATING ON-CHARGE, BUT AFTER A SHORT WHILE, IT TURNED RED THAT MADE THE CHARGING QUITE UNSTABLE. UPON CHECKING THE CONNECTION PORT, 4 PINS OUT OF THE 16 SEEMED TO BE MELTED. WHEN THE HANDLE WAS TAKEN OFF THE CHARGER, AN ERROR DISPLAY WITH A YELLOW FRAME AND HANDLE LIFE REMAINING ZERO WITH A WRENCH MARK ON THE UPPER RIGHT APPEARED. THE ERROR REMAINED EVEN AFTER RESETTING THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10374985 ↗
• MalfunctionJun 25, 2020Break; Failure to Charge; Break; Failure to Charge

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE HANDLE COULD NOT BE CHARGED AND THE FLASHING GREEN LED ON THE BATTERY CHARGING STATION CHANGED TO FLASHING RED AFTER A FEW SECONDS. IT WAS ALSO REPORTED THAT A PIN IN THE CHARGER WAS BROKEN. THE HANDLE ALSO COULD NO LONGER BE AWAKENED FROM SLEEP MODE. THE DISPLAY SHOWED NO INFORMATION. ANOTHER CHARGER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10197448 ↗
• MalfunctionJun 25, 2020Break; Overheating of Device; Break; Overheating of Device

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE HANDLE ZIPPING ION LIQUID FROM BATTERY, AND OVERHEATING DAMAGE CHARGER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10195814 ↗
• MalfunctionJun 25, 2020Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, CHARGER WAS DAMAGED. LIQUID WAS ZIPPING FROM THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10195477 ↗
• MalfunctionMay 27, 2020Failure to Charge; Melted; Product Quality Problem; Failure to Charge; Melted; Product Quality Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE HANDLE COULD NOT BE CHARGE. SOME BLACK MATERIAL WAS FOUND TO BE ADHERED TO THE METAL CHARGING PART OF THE HANDLE. THE CONNECTION PART TO THE HANDLE ON THE CHARGER SIDE WAS ALSO FOUND TO BE MELTED PROBABLY DUE TO LIQUID DRIPPING. TO RESOLVE THE ISSUE IT WAS CHECKED IF CHARGING WAS AVAILABLE WITH A MANUAL DEMONSTRATION HANDLE, BUT THE CHARGER WERE UNABLE TO BE USED ALSO. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10092921 ↗
• MalfunctionMay 20, 2020Break; Failure to Charge; Break; Failure to Charge

  ACCORDING TO THE REPORTER, PRIOR TO A COLON SURGERY, WHEN THE HANDLE WAS CONNECTED TO THE CHARGER, THE BATTERY CHARGER ILLUMINATED RED. THE BATTERY CHARGER WAS CHECKED AND IT WAS NOTED THAT THERE WAS JELLY-LIKE LIQUID AT THE BOTTOM WHERE WAS THE CONTACT POINT WITH THE HANDLE. THERE WAS BURNED-OUT TRACES WERE FOUND ON THE HANDLE CONTACT POINT AND AC CONNECTION PART OF THE BATTERY CHARGER. IT WAS ALSO NOTED THAT THE HANDLE HAD BEEN BLACKOUT. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10077618 ↗
• MalfunctionMay 19, 2020Failure to Charge; Melted; Failure to Charge; Melted

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A LAPAROSCOPIC TOTAL GASTRECTOMY, AT THE FIRST FIRING, WHEN THE CHARGER WAS BEING INSERTED BY THE HANDLE WAS CHECKED, THE RED INDICATOR WAS NOTED TO BE ILLUMINATED. WHEN THE CONNECTION PART WAS BEING CONTACTED BY HANDLE AND THE CHARGER WAS CHECKED, THE EVENT LIKE PIN MELTING WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10069686 ↗
• MalfunctionMay 7, 2020Failure to Charge; Failure to Charge

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE HANDLE WOULD NOT TURN ON AND LITHIUM BATTERY FLUID WAS SPILLED DAMAGING THE CHARGING BAYS. ANOTHER HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10033444 ↗
• MalfunctionApr 24, 2020Failure to Charge; Electrical Power Problem; Failure to Charge; Electrical Power Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE CHARGER DOES NOT RUN/WORK. A NEW CHARGER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9995276 ↗
• MalfunctionApr 16, 2020Failure to Charge; Contamination /Decontamination Problem; Failure to Charge; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE HANDLE WAS BEING CHARGED, THE CHARGER ILLUMINATED RED LIGHT. UPON CHECKING THERE WAS A LIQUID LEAKED INTO THE METAL PIN PART OF THE BOTTOM OF THE HANDLE AND THE HANDLE COULD NOT START-UP. TO RESOLVE THE ISSUE A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9969948 ↗
• MalfunctionApr 15, 2020Leak/Splash; Battery Problem; Leak/Splash; Battery Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE HANDLE WAS REMOVED FROM THE CHARGER, A MARK INDICATING UNABLE TO BE USED APPEARED. AFTER THAT, THE CHARGER DID NOT REACT EVEN THE HANDLE WAS RETURNED TO THE CHARGER. IN ADDITION, LIQUID WAS FOUND TO BE LEAKED ON THE TERMINALS INSIDE THE CHARGER, AND THE CHARGER WAS UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9962275 ↗
• MalfunctionApr 15, 2020Contamination; Corroded; Device Emits Odor; Contamination; Corroded; Device Emits Odor

  ACCORDING TO THE REPORTER, PRIOR TO LAPAROSCOPIC PARTIAL GASTRECTOMY, LIQUID LEAKAGE FROM THE HANDLE WAS FOUND DURING INSPECTION BEFORE USE. LIQUID LEAKAGE WAS FOUND FROM THE CONNECTION PART WITH THE CHARGER, AND THERE WAS ABNORMAL ODOR. THERE WAS DEPOSITION ATTACHED ON THE CHARGER. THE HANDLE CAUSED BATTERY ERROR LAST WEEK, BUT WHEN IT WAS INSERTED INTO THE CHARGER, THE STATUS WAS RESTORED, SO ALTHOUGH THERE WAS ONLY ONE EVENT OCCURRED, THE HANDLE HAS BEEN USED CONTINUOUSLY. THE HANDLE IS CURRENTLY BLACKOUT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9961738 ↗
• MalfunctionApr 15, 2020Corroded; Battery Problem; Corroded; Battery Problem

  ACCORDING TO THE REPORTER, PRIOR A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY (LADG) PROCEDURE, A SIGNIA HANDLE WAS FOUND NOT CHARGED. THE HANDLE WAS RE-INSERTED FOR SEVERAL TIMES BUT THE SITUATION DID NOT IMPROVE. SOMETHING LEAKED ON THE CONNECTION PART OF THE HANDLE TO THE CHARGER, LIQUID WAS FOUND INSIDE THE CHARGER AND THE HANDLE DISPLAYED SAND STORM. THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDLE AND CHARGER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9961710 ↗
• MalfunctionApr 14, 2020Failure to Charge; Device Contaminated During Manufacture or Shipping; Failure to Charge; Device Contaminated During Manufacture or Shipping

  ACCORDING TO THE REPORTER PRIOR TO A LAPAROSCOPIC LOWER ANTERIOR RESECTION, WHEN ATTEMPTING TO REMOVE THE HANDLE FROM THE CHARGER TO PERFORM SETUP, LED OF THE CHARGER WAS FOUND TO BE FLASHING RED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9957013 ↗
• MalfunctionApr 14, 2020Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER USING THE DEVICE, THE POWER HANDLE WAS INSERTED INTO THE BATTERY CHARGER TO BE CHARGED. THE CHARGER INDICATOR WAS FOUND TO BE FLASHING RED BEFORE STARTING THE OPERATION. WHEN THE CONNECTION ELECTRODE PART OF THE CHARGER AND THE HANDLE WAS CHECKED, VISCOUS LIQUID WAS FOUND TO BE ADHERED TO THE ENTIRE CONNECTION PART OF THE CHARGER AND THE HANDLE. THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9956630 ↗
• MalfunctionApr 14, 2020Failure to Charge; Corroded; Battery Problem; Failure to Charge; Corroded; Battery Problem

  ACCORDING TO THE REPORTER, PRIOR TO SIGMOIDECTOMY, WHEN THE POWER HANDLE WAS BEING CHARGED, SOMETHING LIKE SPARK WAS OBSERVED FROM THE CHARGER. THE INDICATOR OF THE CHARGER FLASHED RED, SO THE POWER HANDLE WAS REMOVED. IT WAS TRIED SEVERAL TIMES, BUT THE INDICATOR REPEATED FLASHING GREEN TO FLASHING RED. BLACK DIRT WAS NOTED ON THE ELECTRODE SURFACE OF THE CHARGER AND THE ELECTRODE SURFACE OF THE POWER HANDLE. THE REPORTED POWER HANDLE WAS ATTEMPTED WITH ANOTHER CHARGER, BUT WHEN IT WAS INSERTED, IT POWERED ON IMMEDIATELY AND FULL CHARGE INDICATION WAS DISPLAYED. HOWEVER, WHEN IT WAS REMOVED FROM THE CHARGER, IT COULD NOT BE POWERED ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9956592 ↗
• MalfunctionApr 14, 2020Failure to Charge; Corroded; Product Quality Problem; Smoking; Device Contamination with Chemical or Other Material; Failure to Charge; Corroded; Product Quality Problem; Smoking; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER PRIOR TO LAPAROSCOPY ASSISTED DISTAL GASTRECTOMY, WHILE CHARGING THE HANDLE, SMOKE CAME OUT FROM THE ELECT RODE PART OF THE CHARGER. THEREFORE, THE CHARGING WAS STOPPED. WHEN CHECKING THE HANDLE ELECTRODE PART, SOMETHING LIKE BLACK SOOT WAS FOUND TO BE ATTACHED. THE ELECTRODE SURFACE OF THE CHARGER WAS IN A PARTIALLY MELTED STATE. AFTER THAT, THE HANDLE WAS CHARGED WITH ANOTHER CHARGER, BUT RED INDICATOR FLASHED AND THE CHARGING COULD NOT BE PERFORMED WITH HANDLE; HOWEVER, OTHER HANDLES WERE ABLE TO BE CHARGED WITH THE CHARGER. IN ADDITION, THE POWER ALSO DID NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9956582 ↗
• MalfunctionApr 13, 2020Failure to Charge; Device Contamination with Chemical or Other Material; Failure to Charge; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A PROXIMAL PANCREATICODUODENECTOMY, WHEN THEY WERE CHECKING THE CHARGE STATE OF THE HANDLE, ABNORMAL ODOR WAS NOTED. THE CHARGER'S INDICATOR WAS ALSO NOTED TO BE ILLUMINATING RED, WHEN THE HANDLE WAS REMOVED, LIQUID WAS FOUND TO HAVE LEAKED, AND THE HANDLE WAS IN THE CONDITION OF BLACKOUT. THE COMPETITOR'S DEVICE WAS USED FOR THE SURGERY, THERE WAS NO PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9955735 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160176, K201672. One submission often covers many models, so check the product and lot details in each record.

• Z-1228-2023 · Jan 25, 2023 · Open, Classified
  Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1237-2018 · Dec 13, 2017 · Terminated
  Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Sta