Signia SIGMRETRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521543881), received between Apr 18, 2018 and Dec 19, 2025 — classified as 7 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (25 reports).

14 other recalls cover devices cleared under the same FDA submission (K160176, K201672, K240881); 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. 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING A RELOAD WITH A POWERED STAPLER AND STANDARD ADAPTER, THE PROCEDURE WAS EXTENDED BY 14 MINUTES DUE TO DIFFICULTY RETRACTING THE KNIFE BLADE AFTER FIRING THE RELOAD. THE RELOAD COULD NOT BE RETRACTED, AND THE ADAPTER BECAME STUCK WITH THE LOAD. ATTEMPTS TO RESOLVE THE ISSUE INCLUDED RESETTING THE RETRACTION MECHANISM, REMOVING AND REPLACING THE ADAPTER IN THE RETRACTION MECHANISM, AND USING MANUAL RETRACT TOOLS; HOWEVER, BOTH MANUAL RETRACT TOOLS SPLIT AND BROKE DURING THESE ATTEMPTS. ULTIMATELY, THE SURGEON MANAGED TO RELEASE THE TISSUE WITH FORCEPS BY SLOWLY PULLING IT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847265 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING A RELOAD WITH A POWERED STAPLER AND STANDARD ADAPTER, THE PROCEDURE WAS EXTENDED BY 14 MINUTES DUE TO DIFFICULTY RETRACTING THE KNIFE BLADE AFTER FIRING THE RELOAD. THE RELOAD COULD NOT BE RETRACTED, AND THE ADAPTER BECAME STUCK WITH THE LOAD. ATTEMPTS TO RESOLVE THE ISSUE INCLUDED RESETTING THE RETRACTION MECHANISM, REMOVING AND REPLACING THE ADAPTER IN THE RETRACTION MECHANISM, AND USING MANUAL RETRACT TOOLS; HOWEVER, BOTH MANUAL RETRACT TOOLS SPLIT AND BROKE DURING THESE ATTEMPTS. ULTIMATELY, THE SURGEON MANAGED TO RELEASE THE TISSUE WITH FORCEPS BY SLOWLY PULLING IT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847263 ↗
• MalfunctionNov 27, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LECTURE ON THE USE OF THE POWER MANUAL RETRACT TOOL, THE TOOL WAS DAMAGED, RESULTING IN THE CARTRIDGE AND ADAPTER BECOMING IRREVERSIBLY STUCK AND UNABLE TO BE DETACHED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23667601 ↗
• MalfunctionJul 9, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC RADICAL NEPHRECTOMY, THE RELOAD WAS FIRED ACROSS THE HILUM OF THE KIDNEY. THE POWERED STAPLER FULLY FIRED, BUT IT WOULD NOT RETRACT AND COULD NOT BE OPENED. THE HANDLE WAS REMOVED AND REINSTALLED INTO THE ADAPTER, AS WELL AS FULLY REBOOTED WHILE ON THE ADAPTER, BUT THE KNIFE WOULD STILL NOT RETRACT. THE MANUAL RETRACTION TOOL WAS USED ON THE ADAPTER BY INSERTING IT INTO THE MIDDLE HOLE AND TURNING IT CLOCKWISE. THE TOOL ONLY TURNED A SHORT WAY UNTIL IT STOPPED. IT COULD TURN COUNTERCLOCKWISE BUT WOULD COME TO A STOP WHEN TURNING CLOCKWISE. THE KNIFE BLADE DID NOT APPEAR TO RETRACT AT ALL. THE MANUAL RETRACTION TOOL BROKE WHEN TRYING TO APPLY ADDITIONAL FORCE TO THE MIDDLE HOLE. THERE WAS NO ROOM TO INSERT ANOTHER STAPLER AND STAPLE AROUND THE STUCK RELOAD TO REMOVE IT. WITH NO OTHER OPTIONS, THE SURGEON DECIDED TO CONVERT TO OPEN. ADDITIONAL DISSECTION WAS DONE T O GAIN SPACE AROUND THE HILUM NEAR THE VENA CAVA. EVENTUALLY ENOUGH ROOM WAS OBTAINED TO ALLOW FOR SUTURE LIGATION, AND THE STAPLER COULD BE CUT FREE FROM THE TISSUE. SURGICAL TIME WAS EXTENDED.

  Patient problems: Insufficient Information

  MAUDE report 22465550 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE HANDLE WITH 243 LIVES AND MORE THAN 40 LIVES ON THE ADAPTER, FIRED WITHOUT ISSUE USING THE FIRST RELOAD. THE SECOND RELOAD CYCLED WITHOUT ANY PROBLEMS, BUT JAMMED NEAR THE END OF THE FIRING PROCESS. AN UNKNOWN MESSAGE WITH A YELLOW BACKGROUND APPEARED ON THE SCREEN, ACCOMPANIED BY A BLINKING JAW ICON. ADDITIONALLY, THE ADAPTER SWIM LANE WAS BLACK WITH A GREEN OUTLINE. THE SURGEON RESTARTED THE DEVICE, DISCONNECTED AND RECONNECTED THE ADAPTER. THE HANDLE WAS ALSO REPLACED. TWO RETRACTION TOOLS WERE USED, BOTH OF WHICH BROKE OFF DURING THE ATTEMPT TO RELEASE THE DEVICE. NO COMPONENT FELL ON THE PATIENT'S CAVITY. FINALLY, THE TRAPPED PIECE OF STOMACH HAD TO BE DISSECTED FROM THE RELOAD TO RESOLVE THE SITUATION. THE RELOAD COULD NOT BE UNLOADED ONTO THE ADAPTER EITHER. THE SURGEON REINFORCED THE GASTRIC SLEEVE WITH LAPAROSCOPIC SUTURES. A SECOND ADAPTER WAS USED WITH THE SAME HANDLE TO COMPLETE THE CASE. AFTER THE PROCEDURE, USING THE FIRST HANDLE, THE REPRESENTATIVE WAS ABLE TO R EMOVE THE CLOSED RELOAD FROM THE ADAPTER WITHOUT PRESSING THE BLUE BUTTON (WHICH WAS SLIGHTLY RETRACTED). THE RELOAD WAS TESTED ON THE SECOND AD

  Patient problems: Tissue Breakdown

  MAUDE report 22454977 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE HANDLE WITH 243 LIVES AND MORE THAN 40 LIVES ON THE ADAPTER, FIRED WITHOUT ISSUE USING THE FIRST RELOAD. THE SECOND RELOAD CYCLED WITHOUT ANY PROBLEMS, BUT JAMMED NEAR THE END OF THE FIRING PROCESS. AN UNKNOWN MESSAGE WITH A YELLOW BACKGROUND APPEARED ON THE SCREEN, ACCOMPANIED BY A BLINKING JAW ICON. ADDITIONALLY, THE ADAPTER SWIM LANE WAS BLACK WITH A GREEN OUTLINE. THE SURGEON RESTARTED THE DEVICE, DISCONNECTED AND RECONNECTED THE ADAPTER. THE HANDLE WAS ALSO REPLACED. TWO RETRACTION TOOLS WERE USED, BOTH OF WHICH BROKE OFF DURING THE ATTEMPT TO RELEASE THE DEVICE. FINALLY, THE TRAPPED PIECE OF STOMACH HAD TO BE DISSECTED FROM THE RELOAD TO RESOLVE THE SITUATION. THE SURGEON REINFORCED THE GASTRIC SLEEVE WITH LAPAROSCOPIC SUTURES. A SECOND ADAPTER WAS USED WITH THE SAME HANDLE TO COMPLETE THE CASE. AFTER THE PROCEDURE, USING THE FIRST HANDLE, THE REPRESENTATIVE WAS ABLE TO REMOVE THE CLOSED RELOAD FROM THE ADAPTER WITHOUT PRESSING THE BLUE BUTTON (WHICH WAS SLIGHTLY RETRACTED). THE RELOAD WAS TESTED ON THE SECOND ADAPTER BUT FAILED TO ESTABLISH A CONNECTION OR BE RECOGNIZED. WHEN CONNECTING THE FIRST AD APTER WITH T

  Patient problems: Tissue Breakdown

  MAUDE report 22454972 ↗
• MalfunctionJun 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RECTOSIGMOIDECTOMY PROCEDURE, WHEN CLOSING THE FABRIC, THE EXCESSIVE STOP ICON APPEARED ON THE DISPLAY, THE USER AWAITED ABOUT 20 SECONDS FOR THE FABRIC TO SETTLE AND THE SIGNAL CAME OUT AND IT STARTED STAPLING, UNTIL HALFWAY THROUGH THE MESSAGE APPEARED AGAIN, WE WAITED A LITTLE LONGER AND THE IT DIDN'T EVEN COME OFF THE DISPLAY, SO WHEN IT RESUMED CHARGING, THE STAPLER NO LONGER RESPONDED. MORE. USER TRIED TO CARRY OUT ALL THE MANEUVERS TAUGHT IN THE CERTIFICATION FOR OPENING THE LOAD, HOWEVER, NOTHING WORKED, THE SURGEON DECIDED TO KEEP THE LOAD ATTACHED AND CONTINUE WITH THE SURGERY. IT WAS NO LONGER NECESSARY TO CHANGE, AS THE ROD BROKEN WHEN THE SURGEON TRIED TO OPEN THE LOAD LOCKED IN THE TISSUE, THE USER WAS ABLE TO REMOVED THE ROD FROM THE CAVITY. IT WAS REPLACED WITH ANOTHER ROD FOR A NEW SHOT.

  Patient problems: Tissue Breakdown

  MAUDE report 19638700 ↗
• MalfunctionJun 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A VERTICAL GASTRECTOMY, WHEN USING THE SECOND RELOAD, AFTER FIRING, WHEN TRYING TO RETRACT THE SCALPEL, IT DID NOT RETRACT, THE DEVICE LOCKED ONTO TISSUE. THEN, AN ATTEMPT WAS MADE TO DISCONNECT THE POWER HANDLE FROM THE ADAPTER AND RECONNECT IT, BUT NOTHING HAPPENED. THE POWER HANDLE WAS RESTARTED WITH THE SAME RESULT. FINALLY, IT WAS TRIED WITH A RETRACTION KEY. THE RETRACTION KEY BROKE, AND A SECOND KEY WAS USED. THE RELOAD WAS ADVANCED TO THE END AGAIN. A CLICK WAS HEARD, AND THEN IT WAS RETRACTED WITH THE RETRACTION KEY. A MANUAL RETRACTION WRENCH WAS USED. FINALLY, THE SCALPEL WAS RETRACTED WITHOUT ANY APPARENT DAMAGE IN THE RELOADING OR IN THE STAPLES. THE SURGICAL TIME WAS EXTENDED BY 20 MINUTES DUE TO DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 19636115 ↗
• MalfunctionDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATECTOMY SURGERY WITH ROBOT SUPPORT, AT THE TIME OF PANCREAS RESECTION, THE KNIFE ADVANCED WITH THE FEELING THAT IT WAS PUSHED A LITTLE, THEN STOPPED, THEN PUSHED AND THEN STOPPED, AND SO ON AS THE KNIFE FORWARD (NOT AS MUCH AS TAPPING). AT THAT TIME, EVEN THOUGH THE FIRING BUTTON WAS NOT PRESSED, THE KNIFE SUDDENLY ADVANCED AND FIRED TILL THE END. AFTERWARDS, THE DEVICE COULD NOT BE RELEASED EVEN WHEN THE BUTTON WAS PRESSED AND DISPLAYED A YELLOW EXCLAMATION MARK ABOVE THE ADAPTER SWIMLANE. THE ADAPTER WAS REMOVED AND REATTACHED, BUT THE DEVICE WAS STILL NOT RELEASED. A NEW HANDLE AND SHELL WERE USED, BUT THE ISSUE REMAINED THE SAME. THE SURGEON THEN TRIED RELEASING THE DEVICE USING TWO MANUAL ADAPTER TOOLS, BUT IT WAS SO HARD AND DID NOT TURN AND THE ADAPTER TOOLS WERE DAMAGED. A NEW ADAPTER WAS ATTACHED TO THE DEVICE, BUT THE DEVICE COULD STILL NOT BE RELEASED AND AN ADAPTER SWIMLANE ERROR WAS DISPLAYED. AS A RESULT, A SCALPEL, A GENERATOR, AND A LIGASURE DEVICES WERE USED, AND THE PANCREAS WAS RESECTED ON THE CENTRAL SIDE FROM THE ORIGINALLY INTENDED RESECTION LINE. THIS LED TO ABOUT 30 MINUTES EXTENDED SURGICAL TIME, LESS

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 18416612 ↗
• MalfunctionDec 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATECTOMY SURGERY WITH ROBOT SUPPORT, AT THE TIME OF PANCREAS RESECTION, THE KNIFE ADVANCED WITH THE FEELING THAT IT WAS PUSHED A LITTLE, THEN STOPPED, THEN PUSHED AND THEN STOPPED, AND SO ON AS THE KNIFE FORWARD (NOT AS MUCH AS TAPPING). AT THAT TIME, EVEN THOUGH THE FIRING BUTTON WAS NOT PRESSED, THE KNIFE SUDDENLY ADVANCED AND FIRED TILL THE END. AFTERWARDS, THE DEVICE COULD NOT BE RELEASED EVEN WHEN THE BUTTON WAS PRESSED AND DISPLAYED A YELLOW EXCLAMATION MARK ABOVE THE ADAPTER SWIMLANE. THE ADAPTER WAS REMOVED AND REATTACHED, BUT THE DEVICE WAS STILL NOT RELEASED. A NEW HANDLE AND SHELL WERE USED, BUT THE ISSUE REMAINED THE SAME. THE SURGEON THEN TRIED RELEASING THE DEVICE USING TWO MANUAL ADAPTER TOOLS, BUT IT WAS SO HARD AND DID NOT TURN AND THE ADAPTER TOOLS WERE DAMAGED. A NEW ADAPTER WAS ATTACHED TO THE DEVICE, BUT THE DEVICE COULD STILL NOT BE RELEASED AND AN ADAPTER SWIMLANE ERROR WAS DISPLAYED. AS A RESULT, A SCALPEL, A GENERATOR, AND A LIGASURE DEVICES WERE USED, AND THE PANCREAS WAS RESECTED ON THE CENTRAL SIDE FROM THE ORIGINALLY INTENDED RESECTION LINE. THIS LED TO ABOUT 30 MINUTES EXTENDED SURGICAL TIME, LESS

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 18406601 ↗
• MalfunctionOct 9, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A ROBOTIC LAPAROSCOPIC LOBECTOMY, THE JAWS OF THE DEVICE WAS LOCKED ON THE ARTERY. TROUBLESHOOTING WAS PERFORMED BUT THE ISSUE WAS NOT RESOLVED. THE ROD WAS DISCONNECTED AND CONNECTED AGAIN. BOTH GREEN BUTTONS WERE PRESSED TO RESET THE DEVICE. THE MANUAL RETRACTION TOOL ALSO DID NOT WORK. THE MANUAL RETRACTION TOOL BROKE IN AN ATTEMPT TO OPEN THE RELOAD. THE MEDICAL TEAM TRIED TO UNLOCK IT FOR MORE THAN 30 MINUTES. THE ROBOTIC SURGERY WAS CONVERTED TO OPEN SURGERY TO REMOVE THE STAPLER.

  Patient problems: Insufficient Information

  MAUDE report 17895843 ↗
• MalfunctionJul 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR SURGERY, WHILE FIRING THE SECOND RELOAD AT THE TIME OF RECTAL RESECTION, THE DEVICE STOPPED FIRING MIDWAY. THE ARTICULATION DID NOT STRAIGHTEN, AND THE DEVICE LOCKED ON TISSUE. A MANUAL RETRACTOR WAS USED TO RETURN THE ARTICULATION AND OPEN THE JAWS. THE MANUAL RETRACTOR WAS DAMAGED WHILE ARTICULATING THE DEVICE. IT WAS OBSERVED THAT THE STAPLE LINE THAT WAS FIRED WAS PROXIMALLY INCOMPLETE AND THE DEVICE WAS UNABLE TO UNLOAD. THE SURGEON USED A NEW SET OF POWERED STAPLER AND RESECTED THE TISSUE AGAIN TO RESOLVE THE ISSUE. THIS LED TO TISSUE DEFECT, TISSUE DAMAGE, AND MORE THAN ONE INCH EXTENDED INCISION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17321062 ↗
• MalfunctionJun 21, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGECTOMY PROCEDURE, AFTER CHECKING THE OPENING AND CLOSING OF THE DEVICE WITHOUT REMOVING THE YELLOW TAB, THE USER WAS UNABLE TO REMOVE THE YELLOW TAB. IT WAS FOUND OUT THAT THE YELLOW TAB ON THE RELOAD CONNECTION PART WAS DAMAGED. A SECOND RELOAD WAS THEN USED TO CLOSE THE INSERTION OPENING OF THE ESOPHAGEAL CERVICAL ANASTOMOSIS. HOWEVER, AFTER FIRING THE DEVICE, THE JAWS DID NOT OPEN. THE DISPLAY SHOWED AN EXCLAMATION MARK ON THE RELOAD LANE. WHEN CLOSING OF THE JAWS OPERATION WAS DONE, IT SWITCHED TO THE GAUGE DISPLAY, BUT WHEN THE OPENING OPERATION WAS DONE IT WAS THE SAME. THE SURGEON RECONNECTED AND RESTARTED THE DEVICE, BUT THE ISSUE REMAINED THE SAME. A MANUAL ADAPTER TOOL WAS USED, THE DEVICE ROTATED A LITTLE INITIALLY, BUT THE ROTATION WAS SO STIFF. THEREFORE, THE RETRACTOR GOT DAMAGED AND THE JAWS DID NOT MOVE. A SECOND ONE WAS USE, BUT IT COULD NOT ROTATE THE DEVICE. THE SURGEON THEN USED FORCEPS AND WAS ABLE TO RELEASE THE LOCK AND PULL BACK THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171977 ↗
• MalfunctionJun 12, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT VIDEO-ASSISTED THORACIC SURGERY (VATS), RIGHT UPPER LOBECTOMY, WHILE AT THE UPPER RIGHT LUNG, THE STAPLE RELOAD JAWS WERE LOCKED ON FOURTH FIRING OVER LUNG TISSUE WHEN FIRST HANDLE WAS USED AND THE ADAPTER STOPPED BEING RECOGNIZED. HANDLE WAS REMOVED AND RE-ATTACHED TO THE ADAPTER TO RECALIBRATE, BUT ATTEMPT WAS NOT SUCCESSFUL. NEXT ATTEMPT WAS TO ATTACH A SECOND ADAPTER AND SECOND HANDLE TO UNLOCK THE JAWS, BUT AGAIN IT WAS NOT RECOGNIZED. A RETRACTION COULD NOT OPEN THE JAWS AND THE RETRACTION TOOL BROKE. A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE AND CUT/STAPLED ALONGSIDE THE RELOAD OF THE LOCKED JAWS. THERE WAS AN UNANTICIPATED TISSUE LOSS. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17111650 ↗
• InjuryDec 19, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LUNG BIOPSY, THE JAWS LOCKED ON THE TISSUE AND RELOAD COULD NOT BE REMOVED FROM ADAPTER. THE SURGEON ATTEMPTED TO REMOVE DEVICE WITH RETRACTION TOOL BUT THE TOOL BROKE. THE SURGICAL TIME WAS EXTENDED BY AN HOUR TO WORK ON THE PRODUCT BEFORE CUTTING ALONG PATIENT LUNG USING ANOTHER STAPLER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16006231 ↗
• InjuryNov 2, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LEFT INFERIOR THORASCOPIC LOBECTOMY PROCEDURE, AT THE LEFT LOWER LOBE BRONCHIAL RESECTION, THE TISSUE WAS LOCKED HALFWAY AFTER FIRING THE NEEDLE. THE JAWS WILL NOT OPEN AND THE RELOAD COULD NOT BE RELEASED FROM THE ADAPTER. THE SURGEON USED THE MANUAL ADAPTER TOOL BUT THE SCREW OF THE MANUAL ADAPTER TOOL CAME OFF AND BROKE. IT TOOK ABOUT 30 MINUTES TO TROUBLESHOOT THE DEVICE. AN ADDITIONAL RESECTION WAS PERFORMED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15717341 ↗
• MalfunctionJul 14, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACOTOMY FOR MIDDLE AND LOWER LOBE PULMONARY RESECTION, WHILE AT THE THORACOTOMY LUNG MIDDLE AND LOWER LOBECTOMY, THE INSTRUMENTS WERE TRIED TO BE USED FOR RESECTION, BUT THE EXCESSIVE FORCE MARK APPEARED IMMEDIATELY AFTER THE FIRING. THE FIRING WAS ADVANCED, BUT THE CLAMP COVER STOPPED AT THE LINE AT THE GRADUATION 5, THEY TRIED TO RELEASE IT, BUT IT DID NOT RETURN. THE STAPLE LINE WAS INCOMPLETE AT THE DISTAL. THEY PRESSED AND HELD THE GREEN BUTTON ON BOTH SIDES TO RESTART, BUT THE KNIFE DID NOT RETURN. THE HANDLE WAS REMOVED FROM THE ADAPTER WITH THE POWERED APPROACH AND RE-ATTACHED, BUT IT DID NOT RETURN. THE MANUAL ADAPTER TOOL WAS TAKEN OUT AND AN ATTEMPT WAS MADE TO RELEASE IT, BUT IT WAS HARD AND DID NOT MOVE TO THE RIGHT. ANOTHER ADAPTER AND CARTRIDGE WERE TAKEN AT THE DISCRETION OF THE SURGEON, CONNECTED WITH THE SAME HANDLE, AND AN ADDITIONAL RESECTION WAS PERFORMED BY STAPLING THE SURROUNDING TISSUE TO RESOLVE THE UNANTICIPATED TISSUE LOSS AND A PERMANENT TISSUE DAMAGE. A PART OF IT WAS DISSECTED WITH ANOTHER DEVICE, AND THEY CLAMPED THE TISSUE TOGETHER WITH THE CARTRIDGE, WHICH DID NOT OPERATE, THEN REMOVED IT TO THE SURGICA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15013876 ↗
• MalfunctionJul 13, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHEN THE RECTUM WAS RESECTED DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, SURGEON WAS INFORMED THAT THE JAWS COULD NOT BE OPENED. IT WAS REPORTED THAT THE KNIFE DID NOT RETURN TO ITS ORIGINAL POSITION WHEN THE RECTUM RESECTION WAS ATTEMPTED USING THE POWER HANDLE AND 45AMT INSERTED FROM THE LOWER RIGHT ABDOMINAL TROCAR UNDER SCOPE VIEW. THE KNIFE COULD NOT BE RESTORED EVEN AFTER THE HANDLE WAS REMOVED USING THE POWERED APPROACH AND RE-ATTACHED. A RELEASE OPERATION WAS PERFORMED USING THE MANUAL ADAPTER TOOL, BUT IT WAS STIFF AND DID NOT MOVE. THE ADAPTER TOOL GOT DAMAGED WHILE IT WAS TURNED. THE SURGEON DECIDED TO PERFORM AN ADDITIONAL RESECTION, AND AN 11 CM VERTICAL INCISION WAS ADDED BELOW THE NAVEL AND THE INCISION WAS OPENED WITH A WOUND RETRACTOR. ANOTHER NEW 45AMT WAS USED AND TRIED TO CUT MORE INNER THE ANUS SIDE OF THE INITIAL SEPARATION LINE, BUT THE FIRING STOPPED MIDWAY. AN ADDITIONAL RESECTION WAS PERFORMED USING 60AMT AND THE ANAL SIDE WAS SEPARATED. THE ORAL SIDE WAS ALSO RESECTED WITH 60AMT, THE SPECIMEN WAS SEPARATED FROM THE TISSUE, BUT THE HANDLE WAS OUTSIDE OF BODY WITH CLAMPING THE TROCAR, AND THE CARTRIDGE WHICH CLAMPED THE TISSUE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002044 ↗
• MalfunctionJun 28, 2022Break; Break

  ACCORDING TO THE REPORTER, THE PLASTIC PART OF THE WRENCH ITSELF BROKE. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14846670 ↗
• InjuryJun 9, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC SLEEVE, AFTER FIRING THE SECOND RELOAD AT THE INSICURA ANGULARIS, THE I-BEAM BLADE WOULD NOT RETRACT. TWO MANUAL RETRACTION TOOLS WERE USED BUT AFTER A FEW ATTEMPTS THE RETRACTION TOOL BROKE AND COULD NOT CONTINUE TO RETRACT THE BLADE. SOFT REBOOT FAILED. TWO ALLEN KEYS WERE TRIED TO NO AVAIL. THE ADAPTER AND RELOAD WAS DIFFICULT TO UNLOAD SO THE ADAPTER WITH RELOAD WAS EVENTUALLY PULLED OFF FROM REMNANT STOMACH, CAUSING TEAR ON THE TISSUE (INSICURA ANGULARIS). LAPAROSCOPIC STITCHING WAS REQUIRED TO REPAIR THE DEFECT WITH AN ADDITIONAL OMENTAL PATCH PEXY. PERFORATION AT STAPLE LINE WITH GASTRIC MUCOUS CONTAMINATION WAS OVERSEWN. SURGICAL TIME WAS EXTENDED BY 30 MINUTES. SECOND DAY POSTOPERATIVELY, THE PATIENT WAS SEPTIC, FEBRILE AND TACHYCARDIC. A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED AND HEMATOMA FORMING WAS FOUND. ON DAY 6, THE PATIENT SEVERE UPPER QUADRANT PAIN SO A REPEAT CT SCAN WAS PERFORMED. ON DAY 7, THE PATIENT HAD LAPAROSCOPIC DRAINAGE OF INTRA-ABDOMINAL ABSCESSES, WASHOUT AND TWO DRAINS WERE PLACED. THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS AND ANTIFUNGALS. THE PATIENT REQUIRED A WEEK IN HOSPITAL. THE SAME HA

  Patient problems: Abdominal Pain; Fever; Sepsis; Tachycardia; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 14647027 ↗
• MalfunctionFeb 15, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVER RESECTION, AT GLISSON RESECTION, FIRING STOPPED AFTER ADVANCING ABOUT 30MM. SINCE THE JAWS LOCKED ON THE TISSUE AND IT BECAME UNABLE TO BE RELEASED, THE MANUAL ADAPTER TOOL WAS USED. THE CLAMP COVER DID NOT MOVE EVEN THOUGH IT WAS TURNED. AT THIS POINT, THEY CALLED THE SALES REPRESENTATIVE. A RESTART WAS PERFORMED, RECONNECTING THE POWER HANDLE, AND CONNECTING ANOTHER HANDLE, BUT STILL COULDN'T RELEASE THE JAWS NOR UNLOAD THE CARTRIDGE SO USER TRIED THE MANUAL ADAPTER TOOL AGAIN. SINCE IT WAS IN THE ARTICULATED STATE, THE ADAPTER TOOL WAS USED TO RELEASE THE ARTICULATION. THEY WERE ABLE TO RETURN IT STRAIGHT WITHOUT ANY PROBLEMS, BUT EVEN THOUGH THEY TURNED THE GEAR IN THE CENTER, THE CLAMP COVER DID NOT MOVE BACK AND FORTH. WHEN IT WAS TURNED TO THE RIGHT MANY TIMES, IT BECAME VERY STIFF, AND WHEN THE USER TRIED TO TURN IT FURTHER, THE ADAPTER TOOL SNAPPED AND BROKE OFF. AFTER THAT, AT THE DOCTOR'S DISCRETION, THEY CHECKED THE ADAPTER AND THE CARTRIDGE CONNECTION, AND PULLED THE ADAPTER, IT CAME OFF TOGETHER WITH THE CARTRIDGE. WHEN USER INSERTED ANOTHER ADAPTER THERE, IT SEEMED THAT THE CONNECTION WAS AVAILABLE, BUT EVENTUALLY

  Patient problems: Insufficient Information

  MAUDE report 13539035 ↗
• InjuryDec 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC ESOPHAGUS SURGERY, AFTER TRANSECTING THE ESOPHAGUS, THE TIP OF THE JAWS WOULD NOT OPEN. THE DEVICE WAS CONNECTED TO ANOTHER HANDLE BUT ISSUE WAS NOT RESOLVED. MANUAL APPROACH WAS ATTEMPTED, BUT IT WAS VERY STIFF AND COULD NOT TURN, SO THE ADAPTER TOOL GOT DAMAGED. ESOPHAGUS WAS ADDITIONALLY RESECTED (ON ORAL AND ANAL SIDE) WITH ANOTHER POWERED STAPLER, WHICH RESULTED TO SOME TISSUE LOSS. SURGICAL TIME WAS EXTENDED BY AT LEAST 30 MINUTES. INCISION WAS ALSO EXTENDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12958109 ↗
• MalfunctionMar 18, 2020Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE RELOAD WOULD NOT SEAT INTO THE ADAPTER. ANOTHER ADAPTER WAS USED TO COMPLETE THE CASE. IT WAS ALSO REPORTED THAT THE RETRACTION TOOL ALSO BROKE WHEN OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9848139 ↗
• InjuryJan 7, 2020Entrapment of Device; Mechanics Altered; Entrapment of Device; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A LOW ANTERIOR RESECTION, THEY TRIED TO PERFORM STAPLING ON THE RECTUM WITH THE COMBINATION OF POWERED STAPLER AND RELOAD BUT COULD NOT FIRE, AND FURTHERMORE THE JAWS BECAME UNABLE TO OPEN. AT THAT SITUATION, THEY REMOVED THE ADAPTER FROM THE HANDLE AND USED A MANUAL RETRACTION TOOL, BUT THE ADAPTER TOOL COULD NOT TURN, SO ADDITIONAL TISSUE RESECTION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MIN. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9557619 ↗
• MalfunctionDec 6, 2019Break; Break

  ACCORDING TO THE REPORTER DURING A SLEEVE GASTRECTOMY DURING THE 2ND FIRING ACROSS THE STOMACH, THE DEVICE WAS ABLE TO FIRE HOWEVER THE JAWS OF THE DEVICE LOCKED ON TISSUE, THE ADAPTER WAS REMOVED THEN REATTACHED, THE HANDLE WAS ALSO REBOOTED. A MANUAL RETRACTION TOOL WAS ALSO USED BUT IT BROKE. THE STOMACH WAS LIFTED UP TO SHOW THAT THE SUTURE OF THE REINFORCEMENT MATERIAL HAD ENTANGLED ONTO THE I-BEAM ON THE EXTERNAL SIDE OF THE RELOAD WHICH WAS STOPPING THE IBEAM FROM COMPLETELY RETRACTING. THE SUTURE OF THE REINFORCEMENT MATERIAL WAS CUT, THE RELOAD OPENED AND THEY WERE ABLE TO REMOVE THE RELOAD FROM THE TISSUE. THE RELOAD WAS INSPECTED, AND THERE WAS ONE SINGLE STAPLE IN THE CROTCH OF THE RELOAD THAT WAS STILL IN PLACE BUT WAS MALFORMED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9425680 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160176, K201672, K240881. 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-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• 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