Enseal NSLG2C45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705036014553), received between Nov 21, 2017 and Sep 10, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (21 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50720378 ↗
• MalfunctionFeb 20, 2026Difficult to Open or Close; Material Integrity Problem; Noise, Audible

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE DEVICE COULD BE CLAMPED DURING USE. (THE JAWS COULD NOT OPEN AND CLOSE.) THERE WAS A STRANGE SOUND, SO THE DEVICE MAY HAVE BEEN DAMAGED, BUT IT WAS CONFIRMED THAT NO PIECES WERE LEFT INSIDE THE PATIENT. THERE WAS NO EFFECT ON THE PATIENT. ANOTHER COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401994 ↗
• MalfunctionMay 22, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING ROBOT ASSISTED PROCEDURE, THE DOCTOR FELT THAT THE GRIP WAS HARDER THAN USUAL FROM THE BEGINNING. WHEN THE DEVICE WAS ACTIVATED FOUR TIMES, THE KNIFE COULD PROCEED BUT COULD NOT RETURN. THE HANDLE WAS OPENED WITH HANDS AND COULD BE RELEASED. NO PIECES WERE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073071 ↗
• MalfunctionDec 5, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN UROLOGICAL PROCEDURE, THE JAWS WERE DIFFICULT TO OPEN AND CLOSE. NO PROBLEM FOR THE PATIENT. THE DEVICE WAS REPLACED AND USED. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858287 ↗
• MalfunctionFeb 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING HEMOSTASIS OF A VESSEL, WHEN REMOVING THE PATIENT¿S FORCEPS TO CLEAN THE END OF THE DEVICE, THE SURGEON REALIZES THAT THE FORCEPS ARE NOT WORKING PROPERLY (BREAKAGE WITH METAL ELEMENT REMOVED AND DANGEROUS). USE OF ANOTHER FORCEPS WITHOUT CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639665 ↗
• MalfunctionMar 21, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED WHO FOUND THE DEVICE IN THE FACILITY¿S DEFECTIVE DEVICE BIN THAT THE DEVICE WAS TAGGED ¿DEVICE MALFUNCTIONED DURING CASE¿ ¿CLOSED ON STAPLE AND WOULDN¿T RE-OPEN¿ NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583316 ↗
• MalfunctionMar 16, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A COLORECTAL PROCEDURE THAT THE SURGEON TRIED TO GET CYST OR HARD BODY INTRA OP. THEN WOULD NOT OPEN INSIDE THE BODY. HE FIRED IT BUT IT WOULD NOT OPEN. NO OTHER INFORMATION WAS GIVEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554112 ↗
• MalfunctionJan 3, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED PROSTATECTOMY PROCEDURE THAT THE DEVICE LOCKED ON TISSUE. DEVICE WAS EVENTUALLY REMOVED FROM TISSUE. HOW THE DEVICE WAS REMOVED WAS NOT SPECIFIED. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086808 ↗
• MalfunctionJul 18, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT, DURING AN UROLOGICAL PROCEDURE, THE DEVICE BECAME NOT TO FUNCTION DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042061 ↗
• MalfunctionMay 9, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A THORACIC ESOPHAGECTOMY PROCEDURE THAT AT THE START OF THE PROCEDURE THAT WHEN ATTEMPTING TO ACTIVATE THE JAWS WOULD NOT CLOSE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336464 ↗
• MalfunctionMar 27, 2022Failure to Read Input Signal; Material Integrity Problem; Failure to Read Input Signal; Material Integrity Problem

  IT WAS REPORTED THAT DURING A HAND ASSISTED COLON RESECTION PROCEDURE THAT WHILE USING THE DEVICE ON RADIATED TISSUE THE GENERATOR GAVE AN UNKNOWN ERROR AND THE SURGEON INDICATED THAT SOMETHING "BROKE" IN THE JAWS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925424 ↗
• MalfunctionFeb 25, 2022Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROBOTIC PROSTATECTOMY THE DEVICE JAWS LOCKED INSIDE THE PATIENT. WHILE ATTEMPTING TO REMOVE IT THE JAWS BROKE. NO FRAGMENTS WERE GENERATED AND NO X-RAY WAS REQUIRED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13601553 ↗
• MalfunctionFeb 17, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAWS CLOSED ON TISSUE AND REQUIRED MANUAL INTERVENTION BY PA-C TO OPEN JAWS. USED ROBOTIC GRASPER TO OPEN JAWS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549302 ↗
• MalfunctionNov 3, 2021Component Incompatible; Detachment of Device or Device Component; Difficult to Open or Close; Material Integrity Problem; Component Incompatible; Detachment of Device or Device Component; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT, DURING A ROBOT-ASSISTED TOTAL PROSTATECTOMY, THE JAWS BECAME NOT TO OPEN INSIDE THE ABDOMEN AND COULD NOT TAKE OUT FROM THE TROCAR. THE BOTTOM JAW FELL OFF AND I-BLADE WAS POPPED OUT FROM THE TOP JAWS. THE HANDLE COULD NOT BE GRASPED. THE I-BLADE WAS CAUGHT AND COULD NOT TAKE OUT FROM THE TROCAR. THE SALES REP BROKE THE JAWS TO TAKE THE DEVICE OFF FROM THE TROCAR. THE TROCAR WAS RETURNED TO THE HOSPITAL. NO PIECES FELL INTO THE PATIENT. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745199 ↗
• MalfunctionApr 12, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LOUD CRUNCH WAS HEARD AND THEN DEVICE WOULD NOT FUNCTION. THE JAWS WOULD NOT OPEN OR CLOSE ALL THE WAY. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649866 ↗
• MalfunctionDec 18, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A ROBOT-ASSISTED TOTAL PROSTATECTOMY, THE JAWS BECAME NOT TO OPEN AFTER THE JAWS CLAMPED THE TARGET TISSUE THROUGH THE TROCAR. THE JAWS WERE OPENED BY HAND, BUT THE DEVICE BECAME NOT TO CLAMP AFTER THE ISSUE OCCURRED. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11036187 ↗
• MalfunctionDec 15, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING A TOTALLY EXTRAPERITONEAL APPROACH PROCEDURE, THE BLADE WAS BROKEN OFF DURING USE. THE I-BLADE BROKE IN THE PATIENT¿S BODY. WHEN CUTTING INTO THE PERITONEUM, THE DEVICE MAY HAVE WORKED WITH THE TIP OF THE DEVICE TOUCHING THE TROCAR. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT IS STABLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012433 ↗
• MalfunctionNov 17, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE GENERATOR REQUESTED THE CHANGE OF THE INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10854132 ↗
• MalfunctionOct 12, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE GENERATOR REQUESTED THE CHANGE OF THE INSTRUMENT THE CLAMP WAS CHANGED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10662206 ↗
• MalfunctionSep 25, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A UROLOGICAL SURGERY, THE JAWS DID NOT OPEN AND CLOSE WELL BEFORE USE. THE DEVICE WAS NOT USED FOR THE PATIENT. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10586307 ↗
• MalfunctionMar 13, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE HANDLE WAS NOT CLOSING PROPERLY. IT WAS STICKING AND REQUIRING TOO MUCH FORCE TO FIRE. THE CASE WAS COMPLETED WITH A NEW DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829332 ↗
• MalfunctionMar 3, 2020Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED RADICAL CYSTECTOMY, THE DEVICE JAWS WERE UNABLE TO OPEN AFTER THE DEVICE GRASPED THE TARGET TISSUE. THE DEVICE WAS USED ON THE BLOOD VESSELS. THE BOTH SIDE OF BLOOD VESSEL WAS CUT OFF, AND THE DEVICE WAS RELEASED FROM THE BLOOD VESSEL FORCIBLY. THERE WAS VERY LITTLE BLEEDING AND NO NEED TO CONVERT TO OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9781074 ↗
• MalfunctionFeb 20, 2020Physical Resistance/Sticking

  IT WAS REPORTED THAT BEFORE A ROBOT-ASSISTED UNKNOWN PROCEDURE, THE GAZE WAS STUCK BETWEEN THE JAWS. WHEN THE SALES REP AND MEDICAL ENGINEER CHECKED THE DEVICE AND RETURNED THE HANDLE TO THE HOME POSITION, THE GAZE CAME OUT. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9731880 ↗
• MalfunctionJan 14, 2020Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT, BEFORE ROBOTICS ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY, THE JAWS DID NOT OPEN AND CLOSE SEVERAL TIMES DURING USE. IT OPENED AFTER SEVERAL ATTEMPTS, BUT WHEN THE JAWS CLAMPED A GAUZE, IT WAS UNABLE TO OPEN AND CLOSE AGAIN. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9589019 ↗
• MalfunctionOct 28, 2019Device Fell

  IT WAS REPORTED THAT DURING A THERAPEUTIC WEDGE RESECTION, THE DOCTOR WAS TAKING DOWN ADHESIONS ON LUNG PARENCHYMA WHEN THE TOP MOBILE JAW OF THE ENSEAL INSTRUMENT FELL OFF INTO THE PATIENT. THE DOCTOR RETRIEVED THE BROKEN PIECE FROM THE PATIENT. THE DOCTOR USED A HARMONIC HDI TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9248000 ↗