Valleylab LS10 VLLS10GEN (UDI 10884521512801)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10884521512801), received between Jul 28, 2017 and Sep 30, 2026 — classified as 10 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (55 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Energy Output Problem

  It was reported that during ovarian hysterectomy, the unit despite all checks, the clamp did not achieve normal hemostasis. There was energy delivery noted, no a re-grasp alert with end tone heard when apply to less than 7 mm ligament. Another new device was used but the issue remained the same. Device's handpiece was new and first cycle failed and no good seals was completed. The unit had been placed and procedure was completed with devices. The patient had bleeding but no blood transfusion needed.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50941723 ↗
• InjuryMay 28, 2026Energy Output Problem; Connection Problem

  IT WAS REPORTED THAT SIX (6) HOURS AFTER GASTRIC SLEEVE / SASI (SINGLE ANASTOMOSIS SLEEVE ILEAL BYPASS) PROCEDURE, THE PATIENT HAD 2 PINTS OF BLOOD TRANSFUSION DUE TO HYPOVOLEMIC SHOCK CAUSED BY 1500ML ENDOSCOPIC BLEEDING. A REOPERATION WAS PERFORMED TO DETECT THE BLEEDING SOURCE AND STOP THE BLEEDING. NO MASSIVE TRANSFUSION PROTOCOL (MTP) WAS INITIATED. THE EVENT REPORTEDLY EXTENDED HOSPITALIZATION FOR AN UNKNOWN DURATION AND WAS ADMITTED TO SEMI-INTENSIVE CARE UNIT. IT WAS NOTED THAT DURING A PROCEDURE, THE DEVICE HAD INADEQUATE OR PARTIAL EVIDENCE OF ENERGY DELIVERY AND END TONES BEING HEARD. THE SEAL REPORTEDLY SHOWED EVIDENCE OF ENERGY DELIVERY BUT BLED AT GASTRO-DIAPHRAGMATIC VESSELS, BACK OF THE LEFT PILLARS AFTER CUTTING, AND THE SEALING TIME OF THE VESSEL WAS OBSERVED TO BE SHORT. IT WAS NOTED THAT THE JAWS WERE CLEANED APPROXIMATELY FOUR TIMES DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoglycemic Shock; Laceration(s)

  MAUDE report 25312003 ↗
• MalfunctionJan 12, 2026Device Alarm System; Energy Output Problem; Connection Problem

  IT WAS REPORTED THAT DURING RADICAL AXILLARY LYMPH NODE DISSECTION VIA OPEN APPROACH PROCEDURE, THE DEVICE HAD NO SEAL AS THERE WAS NO EVIDENCE OF ENERGY DELIVERY AND END TONES WERE HEARD. PATIENT HAD MINIMAL BLEEDING. THE CONSOLE WAS REPLACED, AND A NEW LIGASURE CLAMP WAS REQUESTED TO COMPLETE THE PROCEDURE. UPON NOTICING THAT IT WAS NOT FUNCTIONING PROPERLY, THE DECISION WAS MADE TO FINISH THE PROCEDURE WITH A NON-MEDTRONIC HANDPIECE. VIDEO RECEIVED AND SHOWED THAT THE THERE WAS A START TONE FOLLOWED BY END TONE, HOWEVER THE GENERATOR SHOWED AMBER LIGHT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24034885 ↗
• MalfunctionOct 27, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT WAS NOT SEALING PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392169 ↗
• MalfunctionSep 26, 2025Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LIGASURE DEVICE OF THE UNIT HAD POOR BURNING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23153235 ↗
• InjuryAug 15, 2025Device Displays Incorrect Message; Connection Problem; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE, IMMEDIATELY AFTER CONNECTION, THE DEVICE WAS NOT RECOGNIZED BY THE GENERATOR SHOWING ERROR MESSAGE OF RED TRIANGLE WITH 3 BEEPS. THE PHYSICIAN COULD NOT DO THE PROCEDURE AND SET OFF SOME OTHER TIME.

  Patient problems: Insufficient Information

  MAUDE report 22814636 ↗
• MalfunctionJul 10, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE COAGULATION OF THE UNIT DID NOT WORK PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467353 ↗
• InjuryJun 7, 2025Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE DEVICE INITIALLY FUNCTIONED PROPERLY. IT WOULD SEAL WITH EVIDENCE OF ENERGY DELIVERY AND END TONE BUT THERE WAS NO REGRASP ALERT. THE DEVICE WOULD CUT WHEN THE JAWS WOULD NOT OPEN AFTER ABOUT ONE HOUR AND WAS UNABLE TO BE USED. DESPITE THIS, THE POWER APPEARED TO STILL BE REACHING THE DEVICE, AS IT CONTINUED TO MAKE THE USUAL SOUNDS WHEN THE ENERGY BUTTONS WERE PRESSED. ON DAY TWO AFTER THE OPERATION, THE PATIENT HAD APPROXIMATELY 500ML OF BLEEDING DUE TO DIFFICULTY OF ADEQUATELY SEALING OF TRANSECTED OMENTUM AND RETROPERITOBAL TISSUE THAT WAS SELF-LIMITING BUT RESULTED IN A PROLONGED ILEUS. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED BY THREE DAYS, RESULTING IN A TOTAL HOSPITAL STAY OF EIGHT DAYS, DUE TO A DELAYED RETURN OF BOWEL FUNCTION. THE PROCEDURE WAS COMPLETED USING CLIPS AND DIATHERMY LAPAROSCOPICALLY.

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

  MAUDE report 22162806 ↗
• MalfunctionApr 9, 2025Failure to Calibrate; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE UNIT HAD A LEAKAGE AND THE ANIMAL PATIENT HAD A FIRST-DEGREE BURN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21809095 ↗
• MalfunctionJan 24, 2025Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING TESTING, THE UNIT HAD SEAL INCOMPLETE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234826 ↗
• MalfunctionJan 24, 2025Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  ACCORDING TO REPORTER, DURING TESTING, THE DEVICE HAD SEAL INCOMPLETE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229442 ↗
• MalfunctionDec 27, 2024Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDPIECE WAS NOT WORKING PROPERLY. THE SURGEON WAS NOT GETTING THE SEAL HE WOULD NORMALLY EXPECT TO SEE AND IT WAS ONLY SEALING VERY MINIMALLY AND LOOKED FAINT. THE MACHINE GAVE THE TWO-TONE BLEEP AND THE SOUND EMITTED WAS FAINT, HE SAID THAT THE MACHINE WAS NOT ALARMING. HE REQUESTED A SECOND HANDPIECE BE OPENED AND THIS PERFORMED IN A SIMILAR WAY INITIALLY UNTIL HE DECIDED TO ASK THEM TO CHANGE THE LS10 MACHINE. ON USING A REPLACEMENT MACHINE, THE SECOND HANDPIECE WORKED AS NORMAL. THE UNIT WAS SENT TO ELECTRICAL ENGINEERING DEPARTMENT FOR CHECKING. THEY TESTED WITH A NEW HANDPIECE ON DAMP TISSUE AND SAID IT ALL APPEARED OK AND HAVE PUT THE MACHINE BACK INTO CIRCULATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028188 ↗
• MalfunctionOct 10, 2024Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, THE DEVICE HAD SEALING INADEQUATE/PARTIAL (WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD) ON LESS THAT 5MM GREATER OMENTUM AFTER THREE OR FOUR SEALS WHEN USED. THE DEVICE HAD NO ALERT PRESENTED BUT THE SEAL SHOWED EVIDENCE OF ENERGY DELIVERY AND BLED AFTER CUTTING. THE BLOOD LOSS WAS NOT APPRECIABLE. THE DEVICE¿S JAW WAS CLEANED EVERY TIME. THE VLLS10GEN WAS USED FIRST, THEN SWITCHED TO FORCETRIAD BUT THE ISSUE PERSISTED UNTIL ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE FORCETRIAD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20422737 ↗
• MalfunctionSep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD A 10CM 1ST DEGREE BURN ON THE BACK SIDE. THE PATIENT WAS KEPT UNDER OBSERVATION IN THE HOSPITAL FOR A FEW DAYS.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 20150300 ↗
• MalfunctionAug 28, 2024Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, WHEN THE ADRENALECTOMY PROCEDURE STARTED, THE OR NURSE FOUND THAT SEALING WAS NOT COMPLETED ON STANDARD TISSUE THICKNESS RANGE UNDER 7MM TISSUE. THE DEVICE HAD EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD BUT NO ALERT. ANOTHER DEVICE WAS USED TO COMPLETE THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091330 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DAY ONE OF POST OPERATIVE SLEEVE GASTRECTOMY, THE CONSULTANT TRAILED LF1937 ON THE FIRST PATIENT AND THE PATIENT'S HEMOGLOBIN (HB) LEVELS DROPPED FROM 149 TO 115. PATIENT NEEDED A REOPERATION TO FIGURE OUT WHERE THE BLEED WAS COMING FROM (HENCE THE DELAY IN REPORTING AS SURGEON WERE NOT AWARE OF THE REASON FOR POST OP BLEED). PATIENT HAD LOST THREE LITERS OF BLOOD IN ABDOMEN WHICH WAS A OMENTUS VENOUS SLOW BLEED FROM SHORT GASTRICS NEAR THE SPLEEN. OTHERWISE, STAPLE LINES AND PORT SITES WERE NORMAL. POST OP REOPERATION DID NOT TAKE PLACE IMMEDIATELY, AS SUCH SURGEON NEEDED TO AWAIT CONFIRMATION FROM THE HEALTHCARE PROFESSIONAL AS THIS COULD HAVE BEEN CAUSED BY ANYTHING. NO BLOOD TRANSFUSION PERFORMED. REOPERATION WAS CARRIED THE FOLLOWING DAY AND THE INSURGENT SEAL TOOK OVER TWO HOURS TO FIND THAT THE BLEED CAME FROM A BRANCH FROM SHORT GASTRIC WHICH WAS THE DEVICE WAS THE ONLY INSTRUMENT USED AROUND THE BLEEDING SITE DURING THE INITIAL PROCEDURE. THE SURGEON NOTED THAT DURING THE PROCEDURE, THE DEVICE WORKED AS IT SHOULD AND THE SURGEON DID NOT EXPERIENCE ANY INCOMPLETE SEAL NOTIFICATIONS ETC, NORMAL TONES OBSERVED SUCH ACTIVATION TONES HEARD, NO RE-GRAS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19997525 ↗
• MalfunctionJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PATIENT HAD A BURN SEEN AT THE LEFT LABIA BUT NO ONE WAS SURE WHAT CAUSED IT OR HOW IT HAPPENED. THE BURN WAS TREATED WITH JELONET DRESSING APPLIED TO THE AREA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burn(s)

  MAUDE report 19790755 ↗
• MalfunctionJun 25, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD INCOMPLETE SEALING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604796 ↗
• MalfunctionJun 11, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE UNIT DID NOT TURN ON PROPERLY; THE UNIT HAD UNUSUAL POWER ON, THE CIRCLE DID NOT STOP TWISTING, AND DID NOT SEAL.

  Patient problems: Insufficient Information

  MAUDE report 19511394 ↗
• MalfunctionMay 14, 2024Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE ACTIVATED WITHOUT THE ACTIVATION BUTTON BEING PUSHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309943 ↗
• MalfunctionApr 26, 2024Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, INABILITY TO COMPLETE SEALING AND BLEEDING WERE OBSERVED. THE DEVICE CONSTANTLY GAVE THE WARNING THAT THE SEALING HAD BEEN COMPLETED BUT SEALING WAS NOT COMPLETED AND THE PATIENT BLED AFTER CUTTING. THE VESSEL WAS NOT FULLY TRANSECTED USING THE FIRST DEVICE, WHILE VESSEL WAS FULLY TRANSECTED ON THE SECOND DEVICE. BLEEDING OBSERVED DIRECTLY FROM THE SEAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19198244 ↗
• MalfunctionApr 26, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE UNIT HAD INTERMITTENT COAGULATION. THE DOCTORS CLAIMED THAT THE COAGULATION AND THE THERMAL AFFECT FOR THE MACHINE WAS NOT LIKE NORMAL AND NOT WORKING PERFECTLY IN THE VESSEL SEALING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192863 ↗
• MalfunctionApr 24, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD LOW SEALING QUALITY. THERE WAS ENERGY DELIVERY OBSERVED. ACTIVATION AND END TONE WERE HEARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172928 ↗
• MalfunctionApr 4, 2024Energy Output Problem; Connection Problem; Energy Output Problem; Connection Problem

  ACCORDING TO REPORTER, PRIOR TO USE, UNIT HAD LOW SEALING QUALITY AND THE SEAL WAS NOT COMPLETED. ANOTHER GENERATOR WAS USED WITH THE SAME ACCESSORIES AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047059 ↗
• InjuryMar 12, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTAL HYSTERECTOMY WITH UNI-BILATERAL ADNEXECTOMY, THE DEVICE WAS NOT SEALING THE VESSELS PROPERLY ON THE CERVICAL TISSUE. AN ACTIVATION TONE WAS HEARD, NO ERRORS OR ALARMS SHOWED ON THE EQUIPMENT, AN END TONE WAS HEARD AND SEALING WAS COMPLETED. AFTER VARIOUS ATTEMPTS AND INCREASED UTERINE BLEEDING, THE SURGEON REQUESTED FOR ANOTHER LIGASURE DEVICE WHICH DID NOT PERFORM THE CAUTERIZATION HAD ACTIVATION AND END TONE HEARD. THE GENERATOR WAS CHANGED TO FT10 AND THE SURGEON WAS STILL NOT ABLE TO PERFORM THE UTERINE ARTERY CAUTERIZATION. THE PATIENT HAD A BLEEDING OF 500-600 ML DURING THE PROCEDURE AND A SUTURE WITH STRATAFIX OF THE BILATERAL UTERINE ARTERIES WAS PERFORMED BECAUSE BOTH LIGASURE WERE NOT EFFECTIVE IN THE CAUTERIZATION, WHICH EXTENDED THE SURGICAL PROCEDURE FOR 30 MINUTES, BLOOD TRANSFUSION WAS NO LONGER NECESSARY. THE JAWS OF THE LIGASURE HANDPIECE WAS CLEANED WHENEVER IT WAS DIRTY. THE VAGINAL RECONSTRUCTION WAS NOT PERFORMED FOR PATIENT'S SAFETY, WHICH WILL BE PERFORMED IN ANOTHER DATE AFTER THE FULL RECOVERY OF THE PATIENT FROM THE SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18891576 ↗