Harmonic NSLX137SRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705036015482), received between May 7, 2022 and Dec 10, 2024 — classified as 1 death, 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING HER RIGHT COLECTOMY, AND AFTER SIX DAYS OF PERFECTLY STRAIGHTFORWARD POSTOPERATIVE CARE, THE PATIENT OPERATED ON WITH THE TRIAL ENSEAL FORCEPS PRESENTED A SUDDEN AND SIGNIFICANT HEMORRHAGE, WHICH THE RESUSCITATOR AND I (THE SURGEON) WERE ABLE TO RESTORE BY OPERATING EXTREMELY RAPIDLY. WE FOUND THREE LITERS OF BLOOD IN HER BELLY, AND THE ILEO-CAECO-APPENDICULAR ARTERY, SEVERED TO ALLOW THE RIGHT COLECTOMY, WAS BLEEDING AT ITS STUMP. THIS BLEEDING WAS VERY UNUSUAL, AND OCCURRED AT DAY 6 WITHOUT EXPLANATION. THIS ARTERY IS SMALLER THAN AN INFERIOR MESENTERIC ARTERY, WHICH I TREAT IN THE SAME WAY FOR LEFT COLECTOMIES. IN THIS PATIENT, IT WAS RATHER SMALLER, OF THE ORDER OF 5MM. THIS PATIENT MANAGED TO OVERCOME THIS HEMORRHAGIC SHOCK AND IS CURRENTLY CONVALESCING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20893804 ↗
• InjuryOct 7, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EVERY TIME THEY TRIED TO SEAL, IT WOULD OPEN BACK UP AND IT WOULD CAUSE BLEEDING ALONG WITH THE PATIENT LOSING AN ADDITIONAL OVARY DURING A LAP SALPINGECTOMY. THEY TRIED ANOTHER DEVICE AND THEN GOT A DIFFERENT ENERGY DEVICE TO COMPLETE THE CASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20384584 ↗
• InjurySep 25, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A COLON RESECTION THE PATIENT HAD A POST-OP BLEED THREE DAYS AFTER THE CASE. IT DIDN'T EVEN LOOK LIKE THERE WAS A SEAL. PATIENT CONSEQUENCES UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20300527 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIPS OF JAW WAS BROKEN. NEEDED TO GET A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19450349 ↗
• DeathJun 3, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COLORECTAL SURGERY, COMPLEX OPEN SURGERY IN AN ELDERLY PATIENT WITH PREVIOUS SURGERIES, PART OF THE PROCEDURE WAS PERFORMED WITH THE DEVICE NORMAL MAKING SEALS AND CUTS OF TISSUE AND VESSELS. AFTER A FEW HOURS AFTER THE SURGERY (APPROXIMATELY 2 HOURS) DR. INDICATES THAT THEY HAVE TO MANUALLY LIGATE SEVERAL SEAL POINTS MADE WITH A DEVICE, SHOWING THEIR DISCOMFORT WITH SAID DEVICE AND LENGTHENING THE TIME SURGERY DUE TO THE AFOREMENTIONED. A DAY AFTER THE SURGERY THE DOCTOR IS CONSULTED ABOUT THE PATIENT'S CONDITION (ABOUT 9 HOURS) TO WHICH HE COMMENTS AND RESPONDS THAT THE PATIENT IS "MORE OR LESS, THAT SHE IS IN THE ICU (INTERMEDIATE TREATMENT UNIT). THAT THE PATIENT BLED AND REQUIRED A TRANSFUSION BLOOD" BUT THAT "NOW MORE STABLE RECOVERING." AFTER A FEW HOURS AND AT AROUND 11:55 HRS DR. INFORMS ME THAT THE PATIENT "IS VERY SERIOUS STATE AND THAT HE BELIEVES HE WILL HAVE TO RE-OPERATE ON HER." THE DATE OF THE REVISION SURGERY WAS (B)(6) 2024.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Necrosis

  MAUDE report 19446544 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DR. HAD AN ADVERSE EVENT HAPPEN WHILE USING THE DEVICE. HE DID HIS NORMAL ROUTINE WITH SEALING VESSELS (IMA) AND HAD BRISK BLEEDING THAT OCCURRED ALMOST AN HOUR LATER LEADING THEM TO GO OPEN FROM A LAPAROSCOPIC LEFT COLECTOMY TO CONTROL THE BLEEDING. NO PATIENT HARM REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19201304 ↗
• InjuryMar 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SURGEON CLAIMED DEVICE WAS DIRECTLY RESPONSIBLE FOR BLADDER INJURY TO PATIENT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY. HOLE IN THE BLADDER WAS SUTURED WITH VLOC AND HAD A STENT PLACED. AFTER A 120 MINUTE DELAY THE PROCEDURE WAS COMPLETED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18846907 ↗
• InjuryAug 25, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY BILATERAL, AFTER TAKING DOWN MULTIPLE ADHESIONS AND CUTTING/COAGULATING ONE FALLOPIAN TUBE, DOCTOR WENT TO OTHER FALLOPIAN TUBE TO DO THE SAME CUT/COAG. MACHINE/GENERATOR MADE THE NORMAL SOUNDS, UNCLAMPED TISSUE & PATIENT'S TUBE BLEEDING. UNABLE TO CONTROL WITH MULTIPLE ATTEMPTS WITH ENSEAL TO COAG TISSUE. OPENED A LIGASURE LAPAROSCOPIC MARYLAND AND WAS ABLE TO CONTROL BLEEDING ON 2ND ATTEMPT. UNFORTUNATELY, THE PATIENT LOST THAT OVARY DUE TO THE UNCONTROLLED BLEEDING THAT THE ENSEAL COULDN'T STOP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Multiple Organ Dysfunction Syndrome

  MAUDE report 17624347 ↗
• MalfunctionAug 10, 2023Difficult or Delayed Activation; Difficult to Open or Close; Difficult or Delayed Activation; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP COLON PROCEDURE, WHILE THE SURGEON WAS TRANSECTING MESENTERY, THE JAWS STOPPED FUNCTIONING. THEY WOULDN¿T OPEN AND CLOSE. THERE WAS A TWO MINUTE DELAY BUT OPENED ANOTHER ENSEAL TO COMPLETE PROCEDURE. NO FRAGMENTS MADE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498949 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Firing Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Firing Problem

  IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY THE SURGEON HAD A POST OP BLEED IN THEIR DEPARTMENT AFTER USING THE DEVICE. THE PATIENT RETURNED TO THE THEATRE DUE TO THE POST OP BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16952522 ↗
• MalfunctionFeb 14, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAWS DID NOT CLOSED PROPERLY. USE OF ANOTHER DEVICE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373556 ↗
• MalfunctionJan 4, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAWS ON THE DEVICE WAS STUCK IN THE OPEN POSITION. SURGEON HAD TO REMOVE THE TROCAR IN ORDER TO REMOVE THE DEVICE. AFTER A FIVE MINUTE DELAY THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094796 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO THE HYSTERECTOMY PROCEDURE THE DOCTOR HAD A BRING BACK, POSSIBLY DUE TO A HEMATOMA. THERE WERE PATIENT CONSEQUENCES.

  Patient problems: Hematoma

  MAUDE report 15715806 ↗
• InjuryOct 18, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT POST-OP TO THE TOTAL LAP HYSTERECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR. IT WAS REPORTED THAT THERE WAS 1200 CC OF ESTIMATED BLOOD LOSS AND THEY ADMINISTERED FOUR LITERS OF NEW BLOOD OF TRANSFUSION AND FELT VERY STRONGLY THAT THE PRODUCT DIDN'T SEAL APPROPRIATELY. UNKNOWN IF THE PATIENT IS OKAY AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15624519 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO THE HYSTERECTOMY PROCEDURE THE DOCTOR HAD A BRING BACK, POSSIBLY DUE TO A HEMATOMAS. THERE WERE PATIENT CONSEQUENCES.

  Patient problems: Hematoma

  MAUDE report 15580821 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO A WHIPPLE PROCEDURE THE PATIENT DEVELOPED HYPERTENSION AND AN ANASTOMATIC LEAK. THE PATIENT LOST 400 CC'S OF BLOOD. FOUR UNITS OF BLOOD WERE TRANSFUSED INTO THE PATIENT. THE SURGEON WENT BACK IN AND SUTURED TO REPAIR THE LEAK. DURING THE ORIGINAL PROCEDURE EVERYTHING WENT FINE. THE PATIENT IS IMPROVING.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension

  MAUDE report 15401528 ↗
• InjuryAug 23, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN LAR THE SURGEON MOBILIZED AROUND THE IMA. HE THEN TRIPLE BURNED ON THE IMA THEN TRANSECTED ACROSS TO SEAL OFF THE VESSEL. IT DID NOT SEAL. THERE WAS SIGNIFICANT BLEEDING. HE THEN HAD TO OPEN THE PATIENT AND COMPLETE THE CASE IN OPEN STATUS. THERE WAS A DELAY OF 2 HOURS. THE PATIENT LOST 600 CC'S OF BLOOD. THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15278024 ↗
• InjuryAug 22, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT POST OP OF A LOW ANTERIOR RESECTION PROCEDURE THAT THE PATIENT WAS BROUGHT BACK TO THE OR FOR BLEEDING THE NEXT MORNING. DETAILS OF THE REPAIR WERE NOT SHARED. PATIENT STATUS WAS NOT SHARED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15270118 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP BLEED TO THE PROCEDURE TOTAL LAP HYSTERECTOMY, THE PATIENT CAME BACK WITH A VESSEL BLEED. THEY USED THE ENSEAL DURING THE CASE WITH LITTLE BLEEDING. IT IS UNKNOWN OF THE TREATMENT THAT WAS USED TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14322573 ↗