Enseal NSLG2S45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705036014560), received between Mar 20, 2018 and Jun 16, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY THE TEFLON WAS DETACHED DURING USE. THE DEVICE WAS REPLACED. THE SURGERY WAS DELAYED 20 MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216295 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN SURGEON WAS ACTIVATING ON TISSUE, THE TIP OF THE JAW BROKE OFF. THEY RETRIEVED THE TIP, AND A NEW DEVICE WAS USED TO COMPLETE THE CASE WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878145 ↗
• MalfunctionMay 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE; SURGEON USING THE FLEXIBLE DEVICE WHEN ONE SIDE OF THE JAWS BROKE OFF INSIDE THE PATIENT. THE DEFECTIVE INSTRUMENT WAS REMOVED AND GRASPERS WERE USED TO REMOVE THE BROKEN PIECES FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280921 ↗
• MalfunctionApr 19, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY WITH DAVINCI, THE JAWS COULD NOT OPEN, AND THE HANDLE WAS UNLOCKED WITH HANDS. THE DEVICE WAS USED AS USUAL. NO PIECES WERE LEFT INSIDE 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 19142880 ↗
• MalfunctionMar 21, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT, DURING ROBOT ASSISTED PROCEDURE, THE JAWS WERE BROKEN. THE BROKEN PIECE WAS REMOVED FROM BODY. THE DEVICE WAS USED AS USUAL. NO PIECES WERE LEFT INSIDE 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 18949573 ↗
• MalfunctionAug 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  SEE ATTACHED MEDWATCH REPORT NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564428 ↗
• MalfunctionOct 17, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED UROLOGICAL PROCEDURE THE JAWS BEGAN NOT TO OPEN AFTER THE SEALING AND THE CUTTING. THE DEVICE DID NOT CLAMP THE HARD THING. 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 15620469 ↗
• MalfunctionOct 11, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UROLOGICAL PROCEDURE, THE JAWS BECAME NOT TO OPEN/CLOSE 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 15574949 ↗
• MalfunctionJun 8, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE, THE DEVICE DID NOT MEET THE CUSTOMER'S EXPECTATIONS DURING AN UNKNOWN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14636056 ↗
• MalfunctionApr 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THAT THE JAW DISCONNECTED FROM THE DEVICE WHILE MOBILIZING THE CURVATURE OF THE STOMACH. 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 14105212 ↗
• MalfunctionApr 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THAT THE JAW DISCONNECTED FROM THE DEVICE WHILE MOBILIZING THE CURVATURE OF THE STOMACH. 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 14104972 ↗
• MalfunctionMar 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COLON RESECTION THE AREA THAT ARTICULATES 'RIPPED OFF' OF THE DEVICE. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952198 ↗
• MalfunctionMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RSO PROCEDURE, THE TIP OF THE DEVICE BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637386 ↗
• MalfunctionOct 29, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GENERAL PROCEDURE THAT WHEN THE DEVICE WAS ARTICULATED IT WOULD NOT UN-ARTICULATE. 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 12724134 ↗
• MalfunctionOct 29, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GENERAL PROCEDURE THAT WHEN THE DEVICE WAS ARTICULATED IT WOULD NOT UN-ARTICULATE. 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 12723268 ↗
• MalfunctionOct 29, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GENERAL PROCEDURE THAT WHEN THE DEVICE WAS ARTICULATED IT WOULD NOT UN-ARTICULATE. 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 12723069 ↗
• MalfunctionSep 13, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A ROBOT ASSISTED UROLOGICAL PROCEDURE, THE JAWS BECAME NOT TO OPEN DURING USE. 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 12461467 ↗
• MalfunctionAug 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING ROBOTIC ASSISTED TOTAL PROSTATECTOMY, THE JAWS WERE BROKEN. THE BROKEN JAW WAS RETRIEVED. 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 12317993 ↗
• MalfunctionJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROBOTICS ASSISTED LAPAROSCOPIC PROSTATECTOMY, THE UPPER JAW BROKE. THE BROKEN PIECE WAS RETRIEVED. NO PIECES 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 11940072 ↗
• MalfunctionFeb 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAWS BROKE INTO TWO PIECES. BOTH PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359532 ↗
• MalfunctionFeb 4, 2021Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE DOCTOR WAS USING ENSEAL NSLG2S45A TO MOBILIZE THE STOMACH AND THE WAS THROWING AN ERROR CODE IN MIDDLE OF PROCEDURE TRIED TO UNPLUG TO RESET AND DIDN¿T WORK. THERE WAS A FIVE-MINUTE DELAY. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278323 ↗
• MalfunctionDec 3, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY, A PIECE OF THE INNER LINING THAT CONTAINS AN I-BEAM PROTRUDED AWAY FROM THE DISTAL TOP PORTION OF THE JAW BUT STILL SECURED ON THE DEVICE. NO PART OF THE DEVICE SEPARATED FROM THE DEVICE AND NOTHING FELL INTO THE PATIENT. THE SURGEON ASKED FOR A NEW DEVICE AND CONTINUED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10942033 ↗
• MalfunctionNov 17, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED PROCEDURE ON THE MALIGNANT TUMOR OF THE PROSTATE GLAND, THE JAWS BECAME NOT TO OPEN DURING USE. THE DEVICE WAS RELEASED BY CUTTING THE TISSUE AROUND THE DEVICE BY THE ELECTRIC KNIFE. THE BLADE TIP WAS NOT BROKEN OFF AND 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10851782 ↗
• MalfunctionSep 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BUTTON BROKE BEFORE USING THE DEVICE. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10586337 ↗
• MalfunctionMar 13, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED UNKNOWN PROCEDURE, THE KNIFE COULD NOT CUT THE TARGET TISSUE WITH THE JAWS CLAMPED DOWN, AND THE JAWS DID NOT OPEN WHEN THE DEVICE WAS USED ON THE LITTLE THICK SIDE TISSUE OF THE PROSTATE GLAND. 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 9829395 ↗