LigaSure XP LXMJ44SRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10884521830967), received between Oct 16, 2023 and Aug 12, 2026 — classified as 8 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (37 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Energy Output Problem; Intermittent Energy Output

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50221972 ↗
• MalfunctionAug 3, 2026Device Alarm System; Detachment of Device or Device Component; Intermittent Energy Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50121937 ↗
• MalfunctionApr 9, 2026

  REPORTED THAT DEVICE DOES NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24828279 ↗
• MalfunctionMar 25, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE USING THE DEVICE, THE FIRST HANDPIECE FAILED TO SEAL THE VESSEL, PROMPTING THE SURGEON TO OPEN A SECOND HANDPIECE, WHICH ALSO FAILED TO SEAL THE VESSEL. THERE WAS AN ENERGY ACTIVATION AND SEALING ISSUE, WITH NO EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD, RESULTING IN NO SEAL. BLEEDING OCCURRED DURING THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED BY ALMOST 30 MINUTES DUE TO THESE ISSUES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24686942 ↗
• MalfunctionFeb 17, 2026

  44CM MARYLAND LIGASURE MALFUNCTIONED DURING THE CASE. THEN, ATTEMPTING TO USE IT THREW AN "INCOMPLETE SEAL CYCLE" MESSAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364191 ↗
• MalfunctionFeb 11, 2026Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT THE ELECTRICAL PART OF THE HANDPIECE STOPPED WORKING AND IT WAS NOT CAUTERIZING TISSUES. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319538 ↗
• MalfunctionFeb 9, 2026Device Alarm System; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE MARYLAND XP INLINE SEALER/DIVIDER 44CM DEVICE EMITTED A CONTINUOUS BLEEP WITH AN ALERT MESSAGE INDICATING THAT THE HANDLE BUTTON WAS PRESSED AND NOT RELEASED AFTER BEING CONNECTED TO THE FT10 GENERATOR. NOTHING FELL ON PATIENT'S CAVITY SINCE THE DEVICE HAD NOT BEEN ACTIVATED OR INSERTED INTO THE PATIENT. RECONNECTION WAS ATTEMPTED, BUT THE ISSUE PERSISTED. A NEW DEVICE WAS OPENED AND USED SUCCESSFULLY ON THE SAME GENERATOR. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DEVICE'S JAW WAS DAMAGED. PIECES OF THE JAW OVERMOLD WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290839 ↗
• MalfunctionJan 13, 2026Device Alarm System; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE WAS USED TO SEAL LYMPHATIC TISSUE VESSELS LESS THAN 7MM IN THICKNESS. AFTER APPROXIMATELY TWO TO THREE SUCCESSFUL SEALS, MINIMAL BLEEDING OCCURRED FOLLOWING COMPLETION OF SEALING AND DISSECTION. THE DEVICE HAD INADEQUATE OR PARTIAL, WITH THE GENERATOR DISPLAYING AN "INCOMPLETE SEAL / REGRASP TISSUE" ALERT, EVIDENCE OF ENERGY DELIVERY AND END TONES WERE NOTED. THE JAWS WERE CLEANED AS FREQUENTLY AS ESCHAR WAS OBSERVED. ANOTHER LIGASURE DEVICE WAS SUBSEQUENTLY USED WITH THE SAME GENERATOR AND FUNCTIONED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY AND NO BLOOD TRANSFUSION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064160 ↗
• MalfunctionNov 28, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY USING THE DEVICE, WHEN BEING USED TO DISSECT/MOBILIZE TISSUE ALONG THE GREATER CURVE OF THE STOMACH. THE SURGEON REPORTED THAT THE HANDLE WAS FEELING "STICKY" ON CLOSING AND OPENING, THERE WAS NO ISSUE WITH ACTIVATION OR HAEMOSTASIS. THE HANDLE CLOSURE WAS NOT SMOOTH AND FELT LIKE IT WAS STICKING. ANOTHER LIGASURE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669783 ↗
• MalfunctionJul 3, 2025Device Alarm System; Detachment of Device or Device Component; Device Alarm System; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE GENERATOR SCREEN DISPLAYED AN INCOMPLETE SEAL CYCLE MESSAGE WHEN THE SURGEON ATTEMPTED TO ACTIVATE THE DEVICE. THERE WAS NO EVIDENCE OF ENERGY DELIVERY AND NO END TONES HEARD. DESPITE UNPLUGGING AND PLUGGING THE DEVICE IN SEVERAL TIMES, THE ISSUE PERSISTED. THE SURGEON HAD GRASPED ENOUGH TISSUE AND INSPECTED IT FOR OBSTRUCTIONS, BUT THE PROBLEM CONTINUED. ANOTHER LIGASURE DEVICE WAS SUCCESSFULLY USED WITH THE SAME FT10 GENERATOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE TIP OF JAW A WAS BROKEN OFF AND NOT RETURNED AND THE SEAL PLATE ON JAW A WAS LIFTED/DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394000 ↗
• MalfunctionJun 26, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED PANCREATIC TAIL RESECTION, THE DEVICE HAD INSUFFICIENT SEALING DESPITE CONFIRMED ENERGY OUTPUT AND SEAL COMPLETION SOUND. HEMORRHAGING OCCURRED AFTER A KNIFE WAS USED TO RESECT THE TISSUE. IT WAS ALSO NOTED THAT THE JAW AREA WAS CLEAN SINCE IT WAS BEING CLEANED EVERY TIME IT GOT DIRTY. THE DEVICE WAS ALSO CONNECTED TO AN FT10 GENERATOR WITH VERSION 4.0.4 AND ANOTHER LIGASURE DEVICE WAS USED WITH THE SAME GENERATOR SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22334652 ↗
• MalfunctionApr 29, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A SADI (SINGLE ANASTOMOSIS DUODENO-ILEAL BYPASS) PROCEDURE, THE LIGASURE DEVICE EXPERIENCED ENERGY ACTIVATION AND SEALING ISSUES WHILE DISSECTING AROUND THE PYLORUS. THE DEVICE WAS SEALING, BUT AFTER MANIPULATING THE TISSUE, CAPILLARIES IN THE OMENTUM BEGAN OOZING. THESE WERE SUBSEQUENTLY SEALED WITH THE LIGASURE DEVICE. THE SEALING WAS INADEQUATE OR PARTIAL, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THERE WAS NO RE-GRASP ALERT. THE TISSUE TYPE BEING SEALED WAS OMENTUM. THE JAWS WERE CLEANED DURING THE PROCEDURE WHEN BUILDUP OCCURRED. THE LIGASURE DEVICE WAS PLUGGED INTO A GENERATOR AND ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THE PATIENT WAS DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21924554 ↗
• InjuryApr 29, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT NEXT DAY AFTER A LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) PROCEDURE, THE PATIENT EXPERIENCED A BLEED AT THE OMENTUM SITE WHERE DISSECTION BEGAN. THE PROCEDURE INITIALLY APPEARED SUCCESSFUL, BUT THE PATIENT'S CONDITION DETERIORATED THE FOLLOWING DAY, NECESSITATING A RETURN TO THE THEATRE. THE BLEED WAS IDENTIFIED AND SURGICALLY RESOLVED. THE PATIENT ALSO HAD AN EXTENDED HOSPITALIZATION. THE DEVICE WAS CONNECTED TO AN FT10 GENERATOR AND IT WAS NOTED THAT THERE WERE NO ISSUES WITH BOTH PRODUCTS DURING USE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21924522 ↗
• InjuryApr 28, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A SADI (SINGLE ANASTOMOSIS DUODENO-ILEAL BYPASS) PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE BLEED, WHICH WAS IDENTIFIED IN THE OMENTUM AROUND THE PYLORUS UPON BEING TAKEN BACK TO THE THEATRE. THE PATIENT UNDERWENT AN EXTENDED HOSPITALIZATION AND THE SITUATION WAS CONSIDERED LIFE-THREATENING. THE DEVICE WAS USED DURING THE PROCEDURE, AND IT WAS CONFIRMED THAT THE DEVICE WAS PLUGGED INTO A GENERATOR. THERE WERE NO ISSUES REPORTED WITH THE DEVICE DURING ITS USE. ANOTHER HANDPIECE WAS USED WITH THE SAME GENERATOR AND IT WORKED SUCCESSFULLY. THE BLEED WAS RESOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21919444 ↗
• MalfunctionApr 24, 2025Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY WHEN APPLIED TO THE GASTRO-EPIPLOIC ARTERY TO ACCESS THE PLANE FOR DISSECTION ALONG THE GREATER CURVATURE, THE DEVICE HAD INADEQUATE OR PARTIAL SEALING, DESPITE EVIDENCE OF ENERGY DELIVERY AND END TONES BEING HEARD. THERE WAS NO RE-GRASP ALARM. PATIENT HAD BLEEDING OF APPROXIMATELY 3-5 ML ON THE THIRD SEAL AFTER CUTTING APPROXIMATELY 5 MM THICK WITH A 1-2 MM VESSEL IN THE FRONT 50% OF THE JAWS OF THE GASTRO-EPIPLOIC ARTERY WITH OMENTUM, BUT BLOOD TRANSFUSION WAS NOT NECESSARY OR DONE TO PATIENT DUE TO THIS BLEEDING. THE PROCEDURE WAS COMPLETED BY USING THE SAME LIGASURE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902886 ↗
• MalfunctionApr 21, 2025Device Alarm System; Energy Output Problem; Intermittent Energy Output; Device Alarm System; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A BARIATRIC SLEEVE PROCEDURE USING THE LIGASURE DEVICE, THERE WAS AN INCOMPLETE SEAL ALARM. THE SEALING WAS INADEQUATE OR PARTIAL, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. DESPITE THIS, MINIMAL BLEEDING OCCURRED AFTER CUTTING. THERE WAS NO BLOOD TRANSFUSION NECESSARY OR DONE TO PATIENT DUE TO THIS BLEEDING. THE DEVICE CONTINUED TO ALARM ABOUT AN INCOMPLETE SEAL, AND DIFFERENT BITES OF VARYING THICKNESS TISSUE WERE ATTEMPTED WITHOUT RESOLUTION. THE DEVICE WAS USED ON OMENTUM TISSUE APPROXIMATELY 5 MM THICK, AND THE JAWS HAD JUST BEEN OPENED AND WERE CLEAN. THE HANDPIECE WAS ABLE TO COMPLETE 1-2 GOOD SEALS BEFORE THE ISSUE OCCURRED. THE GENERATOR USED WAS AN FT10, AND ANOTHER LIGASURE DEVICE WAS SUCCESSFULLY USED WITH THIS GENERATOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21877115 ↗
• MalfunctionMar 19, 2025

  PATIENT HAS FAILED CONSERVATIVE EFFORTS TO LOSE WEIGHT. PATIENT WAS BROUGHT TO THE OPERATING SUITE IN STABLE CONDITION, WAS POSITIONED SUPINE WITH PNEUMATIC COMPRESSION SLEEVES PLACED TO THE LEGS. PATIENT ALSO RECEIVED GENERAL ANESTHESIA AND WAS INTUBATED. ABDOMEN WAS PREPPED AND DRAPED IN STERILE FASHION. TIMEOUT WAS PERFORMED. WHEN IT WAS TIME TO USE THE LIGASURE SEALER/ DIVIDER, THE SURGEON NOTED THAT THERE WAS NOT ENOUGH ENERGY TO MAKE THE DEVICE FUNCTION WELL (DEVICE WAS "WEAK", PER SURGEON.) THE MED FIELD REPRESENTATIVE WAS CONTACTED WHETHER THEY COULD INCREASE THE STRENGTH, BUT THE ANSWER WAS NO. SO, THE DEVICE WAS CHANGED TO A SIMILAR ONE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO PATIENT HARM. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LIGASURE XP (PER SITE REPORTER). FIELD REPRESENTATIVE [REDACTED] WAS CONTACTED AND WILL RETRIEVE THE DEVICE AS SOON AS POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641780 ↗
• MalfunctionFeb 18, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING SLEEVE GASTRECTOMY, THE HANDPIECE HAD INADEQUATE/PARTIAL SEALING. THERE WAS NO RE-GRASP ALERT BUT THERE WAS EVIDENCE OF ENERGY DELIVERY AND END TONES WERE HEARD. IT HAD 4 BLEEDS APPROXIMATELY 100ML ON THE WAY UP THE LESSER CURVE. THE SURGEON WENT BACK OVER BLEEDING AREAS AND ACTIVATED APPROPRIATELY 5X TO GAIN HEMOSTASIS. A NEW HANDPIECE WAS USED AND IT WORKED FINE. BLOOD TRANSFUSION WAS NOT REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21397899 ↗
• MalfunctionJan 31, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE DEVICE HAD SEALING INADEQUATE/PARTIAL (NO REGRASP ALERT BUT WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD) WHEN TAKING THE DOWN GASTRIC VESSELS. THE DEVICE HAD NO GOOD SEAL AND WIPED FOUR TIMES TO CLEAN THE JAWS DURING THE CASE. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285311 ↗
• MalfunctionJan 28, 2025

  PER SURGEON'S NOTES: PATIENT WAS BROUGHT TO THE OPERATING ROOM IN STABLE CONDITION HAVING RECEIVED ANTIBIOTICS. SHE WAS POSITIONED SUPINE AND PNEUMATIC COMPRESSION DEVICES WERE PLACED TO THE LEGS. SHE THEN RECEIVED GENERAL ANESTHESIA, WAS INTUBATED AND AN OROGASTRIC TUBE WAS PLACED INTO THE STOMACH. THE ABDOMEN WAS PREPPED AND DRAPED IN STERILE FASHION. TIMEOUT WAS PERFORMED. GASTROCOLIC LIGAMENT NOW OPENED ON THE GREATER CURVATURE OF THE STOMACH WITH THE VESSEL-SEALING DEVICE AND THE LESSER SAC ENTERED. LIGASURE WOULD NOT SEAL VESSELS. PATIENT CONTINUED TO BLEED WITH MULTIPLE ATTEMPTS TO SEAL. THE DEVICE WAS CHANGED TO ANOTHER SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT HARM. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LIGASURE XP (PER SITE REPORTER). FIELD MED REPRESENTATIVE HAS BEEN INFORMED AND WILL RETRIEVE THE DEVICE IN THE NEAR FUTURE PER OPERATING ROOM SUPERVISOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21251258 ↗
• MalfunctionJan 22, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE FOR DISSECTION OF THE OMENTUM, THE HANDPIECE HAD AN INAD EQUATE/PARTIAL SEAL (WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD). THERE WAS A 30 ML BLEEDING AFTER CUTTING. THERE WAS NO RE-GRASP ALERT, AND NO BLOOD TRANSFUSION WAS NECESSARY OR DONE TO THE PATIENT. THE DEVICE WAS CONNECTED TO THE GENERATOR WITH SOFTWARE VERSION 4.0.4. AND WAS REPLACED BY ANOTHER DEVICE, AND IT WORKED FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21210015 ↗
• MalfunctionJan 10, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE , GASTROCOLIC LIGAMENT WAS NOW OPENED ON THE GREATER CURVATURE OF THE STOMACH WITH THE VESSEL-SEALING DEVICE AND THE LESSER SAC WAS ENTERED. SHORT GASTRIC VESSELS THEN DIVIDED CEPHALAD ALONG THE GREATER CURVATURE. JUST PRIOR TO REACHING THE FUNDUS AND THE ANGLE OF HIS, AN AREA THAT HAD BEEN SEALED BY THE VESSEL SEALER NOW SPONTANEOUSLY STARTED BLEEDING AND THIS WAS INITIALLY PACKED WITH A MINI LAPAROTOMY PAD AND THEN IT WAS ADDRESSED LATER DURING THE CASE. THE BLEEDING WAS CONTROLLED WITH FURTHER APPLICATIONS OF A NEW VESSEL SEALING DEVICE. EVENTUALLY, THE ENTIRE FUNDUS WAS MOBILIZED AND THE LEFT CRUS OF DIAPHRAGM CLEARLY SEEN. SHORT GASTRIC VESSELS THEN DIVIDED CAUDAD ALONG THE STOMACH REACHING A DISTANT 6 CM AWAY FROM THE PYLORUS. AGAIN, THE VESSEL SEALER FAILED TO ADEQUATELY SEAL THE VESSELS IN THIS AREA AND ONCE DISSECTION WAS BEING PERFORMED, THESE VESSELS NOW STARTED SPONTANEOUSLY BLEEDING AND THEN WE HAD TO ACTUALLY OBTAIN A THIRD DEVICE TO STOP THIS FROM HAPPENING. THE 3RD DEVICE WAS WORKING APPROPRIATELY AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21124424 ↗
• MalfunctionJan 10, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE PROCEDURE, GASTROCOLIC LIGAMENT WAS NOW OPENED ON THE GREATER CURVATURE OF THE STOMACH WITH THE VESSEL-SEALING DEVICE AND THE LESSER SAC WAS ENTERED. SHORT GASTRIC VESSELS THEN DIVIDED CEPHALAD ALONG THE GREATER CURVATURE. JUST PRIOR TO REACHING THE FUNDUS AND THE ANGLE OF HIS, AN AREA THAT HAD BEEN SEALED BY THE VESSEL SEALER NOW SPONTANEOUSLY STARTED BLEEDING AND THIS WAS INITIALLY PACKED WITH A MINI LAPAROTOMY PAD AND THEN IT WAS ADDRESSED LATER DURING THE CASE. THE BLEEDING WAS CONTROLLED WITH FURTHER APPLICATIONS OF A NEW VESSEL SEALING DEVICE. EVENTUALLY, THE ENTIRE FUNDUS WAS MOBILIZED AND THE LEFT CRUS OF DIAPHRAGM CLEARLY SEEN. SHORT GASTRIC VESSELS THEN DIVIDED CAUDAD ALONG THE STOMACH REACHING A DISTANT 6 CM AWAY FROM THE PYLORUS. AGAIN, THE VESSEL SEALER FAILED TO ADEQUATELY SEAL THE VESSELS IN THIS AREA AND ONCE DISSECTION WAS BEING PERFORMED, THESE VESSELS NOW STARTED SPONTANEOUSLY BLEEDING AND THEN WE HAD TO ACTUALLY OBTAIN A THIRD DEVICE TO STOP THIS FROM HAPPENING. THE 3RD DEVICE WAS WORKING APPROPRIATELY AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21124238 ↗
• MalfunctionJan 10, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY WITH OMENTOPEXY AND LAPAROSCOPIC BILATERAL TRANSVERSUS ABDOMINIS PLANE (TAP) BLOCK, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM IN STABLE CONDITION, POSITIONED SUPINE AND RECEIVED GENERAL ANESTHESIA/ INTUBATED. ABDOMEN WAS PREPPED AND DRAPED IN STERILE FASHION. ABDOMEN WAS ENTERED AFTER INFILTRATION OF LOCAL ANESTHESIA. GASTROCOLIC LIGAMENT WAS OPENED ON THE GREATER CURVATURE OF THE STOMACH WITH THE VESSEL-SEALING DEVICE AND THE LESSER SAC WAS ENTERED. SHORT GASTRIC VESSELS THEN DIVIDED CEPHALAD ALONG THE GREATER CURVATURE. JUST PRIOR TO REACHING THE FUNDUS AND THE ANGLE OF HIS, AN AREA THAT HAD BEEN SEALED BY THE VESSEL SEALER NOW SPONTANEOUSLY STARTED BLEEDING AND THIS WAS INITIALLY PACKED WITH A MINI LAPAROTOMY PAD AND THEN IT WAS ADDRESSED LATER DURING THE CASE. THERE WAS AN OBVIOUS BLEEDING VESSEL WHICH HAD BEEN PREVIOUSLY SEALED AND CUT WHICH WAS NOW BLEEDING OBVIOUSLY, AND THIS WAS CONTROLLED WITH FURTHER APPLICATIONS OF THE VESSEL SEALING DEVICE. EVENTUALLY, THE ENTIRE FUNDUS WAS MOBILIZED AND THE LEFT CRUS OF DIAPHRAGM CLEARLY SEEN. SHORT GASTRIC VESSELS THEN DIVIDED CAUDAD ALONG THE STOMACH REACHING A DIS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21124116 ↗
• MalfunctionJan 10, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY WITH OMENTOPEXY LAPAROSCOPIC BILATERAL TAP BLOCK, THE GASTROCOLIC LIGAMENT WAS OPENED ON THE GREATER CURVATURE OF THE STOMACH WITH THE VESSEL-SEALING DEVICE AND THE LESSER SAC WAS ENTERED. THERE WAS IMMEDIATE PARTIAL FAILURE OF THE VESSEL-SEALING DEVICE AND THAT THERE WAS BLEEDING AFTER THE DEVICE WAS DEPLOYED AND USED TO CUT. THE AREA WAS RE-SEALED, AND THIS ACHIEVED HEMOSTASIS. HOWEVER, LATER IN THE CASE, THE ISSUE HAPPENED AGAIN. THE SURGEON THEREFORE EXCHANGED FOR A NEW DEVICE, WHICH FUNCTIONED APPROPRIATELY. THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENCE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21124030 ↗