Enseal NSEALX22LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705036013808), received between Apr 25, 2018 and Sep 21, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2020Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  TITLE: A MULTICENTER COHORT ANALYSIS OF LAPAROSCOPIC HEPATIC CAUDATE LOBE RESECTION AUTHOR(S): M. CAPPELLE & D. L. AGHAYAN & M. J. VAN DER POEL & M. G. BESSELINK & G. SERGEANT & B. EDWIN & I. PARMENTIER & C. DE MEYERE & F. VANSTEENKISTE & M. D¿HONDT CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2020) 405:181¿189; DOI: HTTPS://DOI.ORG/10.1007/S00423-020-01867-2. THIS MULTICENTER RETROSPECTIVE COHORT STUDY AIMED TO REPORT ON OUTCOMES, CLARIFY TECHNICAL ASPECTS, AND ANALYZE INTERINSTITUTIONAL DIFFERENCES OF LAPAROSCOPIC RESECTION OF THE CAUDATE LOBE (LRCL). BETWEEN JAN200 AND MAY2018, 32 PATIENTS (N=20 MALE; MEDIAN AGE OF 61 YEARS) WITH COLORECTAL METASTASIS (N=22), OTHER (N=4), CHOLANGIOCARCINOMA (N=1), AND BENIGN DISEASE (N=5) UNDERWENT LAPAROSCOPIC HEPATIC CAUDATE LOBE RESECTION. IN THE PROCEDURE, THE SUPERFICIAL HEPATIC PARENCHYMA IS TRANSECTED USING AN ULTRASONIC SCALPEL (ULTRACISION, ETHICON ENDO-SURGERY INC., CINCINATTI, OH, USA) OR BIPOLAR SEALING DEVICE (ENSEAL G2 TISSUE SEALER, ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA). ONE PATIENT WAS CONVERTED TO OPEN APPROACH WHEN A BLEEDING OF THE INFERIOR VENA CAVA (IVC) WAS ENCOUNTERED. POSTOPERATIVE COMPLICATIONS INCLUDED INTRAABD

  Patient problems: Abscess; Blood Loss; Tissue Damage

  MAUDE report 10561100 ↗
• MalfunctionFeb 13, 2019Break; Loose or Intermittent Connection; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROSTATECTOMY PROCEDURE, THE INTERNAL MECHANISM OF MOVABLE TOP JAW BROKE. THE MOVABLE TOP JAW WAS DAMAGED/LOOSE AND WAS STILL ATTACHED TO THE DEVICE, BUT WAS NOT ABLE TO OPEN OR CLOSE. THE SURGEON ATTEMPTED TO MANUALLY OPEN THE JAWS AND THE DEVICE WAS NOT ON A VESSEL OR ARTERY WHEN IT WOULD NOT OPEN. THE SURGEON DID NOT CONTINUE THE CASE WITH THE SAME DEVICE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338169 ↗
• MalfunctionFeb 13, 2019Break

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, DURING MESORECTAL DISSECTION, THE INTERNAL MECHANISM OF THE MOVABLE TOP JAW BROKE. THE MOVABLE TOP JAW WAS DAMAGED/LOOSE AND WAS STILL ATTACHED TO THE DEVICE, BUT WAS NOT ABLE TO OPEN OR CLOSE. THE SURGEON ATTEMPTED TO MANUALLY OPEN THE JAWS AND THE DEVICE WAS NOT ON A VESSEL OR ARTERY WHEN IT WOULD NOT OPEN. THE SURGEON DID NOT CONTINUE THE CASE WITH THE SAME DEVICE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338149 ↗
• MalfunctionNov 30, 2018Loose or Intermittent Connection; Fitting Problem

  IT WAS REPORTED THAT DURING THE LIMB SALVAGE PROCEDURE, THE CLAMP JAWS DID NOT LOCK AND IT DID NOT CLOSE. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8119382 ↗
• MalfunctionApr 25, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE JAW OF THE SUPER JAW CLAMP DID NOT OPEN AFTER BEING ACTIVATED AND THE CYCLE FINISHED, THE EQUIPMENT PRESENTED AN ERROR CODE THAT SAID TO CHANGE THE DEVICE DUE TO MALFUNCTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457837 ↗