Valleylab E2750Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10884524000435), received between Jun 28, 2016 and Dec 13, 2021 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (10 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WHEN AN ATTEMPT WAS MADE TO CONCEAL THE ELECTRODE, THE HANDSET WITH THE ELECTRODE CAME OFF.

  Patient problems: Insufficient Information

  MAUDE report 12990886 ↗
• MalfunctionAug 31, 2021Electrical Shorting; Electrical Shorting

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS AN ELECTRIC LEAKAGE FROM THE TIP OF THE DEVICE. THERE WERE SEVERAL OCCASIONS THAT THE SURROUNDING TISSUE WAS ENERGIZED DUE TO ELECTRIC LEAKAGE DURING THE OPERATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12395307 ↗
• MalfunctionAug 4, 2021Electrical Shorting; Electrical Shorting

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ELECTRICAL LEAKAGE (SPARK) WAS NOTED FROM THE TIP OF DEVICE. THERE WAS NO DAMAGE TO MULTIPLE ORGANS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276176 ↗
• MalfunctionJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD A BURN-LIKE MARKS ON THE UPPER ABDOMEN (SKIN). THE BURN-LIKE MARKS WERE FROM THE SHAFT OF THE OPTI4 PROBE AND FROM THE FORCEPS, ETC. IT WAS ELONGATED MARK LIKE FORCEPS. WHEN THE LINEN WAS PEELED OFF, THE SKIN ALSO PEELED OFF TOGETHER, RESULTING IN SYMPTOMS OF BURNS. THE PROCEDURE WAS COMPLETED WITHOUT DOING ANYTHING.

  Patient problems: Burn(s)

  MAUDE report 12170831 ↗
• MalfunctionJul 14, 2021Arcing; Electrical Shorting; Arcing; Electrical Shorting

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLON RESECTION, THE DEVICE HAD AN ELECTRIC LEAKAGE (SPARK) FROM THE TIP, 3 HOURS AFTER THE OPERATION WAS STARTED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 12168342 ↗
• InjuryMay 10, 2021Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THREE DEVICES WERE USED. THE FIRST ONE, ABOUT TWO HOURS AFTER THE START, ELECTRIC LEAKED FROM THE ARTICULATION HOLE ON THE BACK OF THE ELECTRODE AND BURNED THE MESENTERIUM. THE ELECTRODE WAS REPLACED AND THE SECOND ONE HAD ELECTRIC LEAKAGE IN ABOUT 15 MINUTES. THE THIRD ONE HAD ELECTRIC LEAKAGE 1 HOUR AFTER REPLACEMENT. ABOUT 1 CM OF MESENTERIUM WAS BURNT. ONLY HEMOSTASIS OPERATION WAS PERFORMED IN PARTICULAR TO SOLVE THE PROBLEM, AND THERE WAS NO EXTENSION PERIOD OF HOSPITALIZATION. TISSUE DAMAGE OR UNEXPECTED TISSUE DEFECT OCCURRED. ELECTRIC LEAKAGE OCCURRED FROM THE ELECTRODE AND THE MESENTERIUM WAS BURNT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11796571 ↗
• MalfunctionApr 16, 2021Arcing; Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Arcing; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 10 MINUTES AFTER THE START OF USE ON LAPAROSCOPIC SIGMOIDECTOMY RESECTION, THE PENCIL HAD AN ELECTRIC LEAKAGE OCCURRED BY SPARKING FROM THE REAR ARTICULATION HOLE AND THE SPATULA CHANGED OF THE SHAPE AND NO INSULATION INSIDE THE CYLINDER. THE SPATULA WAS REPLACED, BUT A SIMILAR EVENT WAS IMMEDIATELY OCCURRED, AND EVEN THOUGH THE ELECTRODE WAS REPLACED AGAIN, THEN THE SURGERY WAS COMPLETED WITHOUT REPLACEMENT. ACTIVATION AND SUCTION CLEANING WERE NOT USED SIMULTANEOUSLY. THE ELECTROSURGICAL ELECTROCAUTERY USED WAS FT10. PATIENT HAD FIRST DEGREE BURN (1CM) ON THE TISSUE IN CONTACT AND DAMAGE OCCURRED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 11679080 ↗
• MalfunctionFeb 18, 2021Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICES SHAPE CHANGE DUE TO MINIATURIZATION OF THE HALL, DIRT WAS EASILY CLOGGED AND ELECTRIC LEAKAGE WAS LIKELY TO OCCUR. THE BOWEL AND MESENTERY WERE BURNT ABOUT 1 CM DUE TO CURRENT LEAKAGE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11342627 ↗
• MalfunctionFeb 9, 2021Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, WHEN REMOVING THE ADHESION TO THE BOWEL FROM THE ABDOMINAL WALL, WITHIN ONE HOUR WHEN SURGERY BEGAN, CURRENT LEAKED FROM THE ARTICULATION HOLE ON THE BACK OF THE ELECTRODE TO THE PROXIMAL TISSUE AND SPARKED, CAUSING THE BOWEL TO BE BURNED, THERE WAS FIRST DEGREE BURN, REDNESS. THE BOWEL BURNED ABOUT ONE CM. THERE WAS NO NEED TO REPAIR. THERE WAS NO PROBLEM WITH THE HANDLE. THE PRODUCT WAS REPLACED WITH THE SAME HAND SWITCHING PENCIL.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 11301190 ↗
• MalfunctionJan 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S ELECTRODE PART AT THE TIP BROKE OFF HALFWAY AND FELL INTO THE ABDOMINAL CAVITY. ALL PARTS WERE RETRIEVED. REPLACED WITH A NEW DEVICE AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11148206 ↗
• MalfunctionOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, WHEN PERFORMING OPERATION IN THE PELVIS WITH THE OPTI4, ACTIVATION WAS NOT OUTPUT FROM THE ELECTRODE, BUT FROM THE HANDPIECE PART, AND THE TISSUE GOT BURNED. THEY REPLACED IT WITH A NEW ONE, BUT THE SITUATION DID NOT CHANGE AND THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: Burn(s)

  MAUDE report 10623195 ↗
• MalfunctionSep 14, 2020Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ELECTRICITY LEAKED FROM THE ARTICULATION HOLE OF THE DEVICE. THE TISSUE GOT IN AND CAUSED ELECTRICITY LEAKAGE. THE PROXIMAL TISSUE, LESS THAN 1CM, WAS BURNT.

  Patient problems: Burn(s)

  MAUDE report 10532286 ↗
• MalfunctionOct 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TIP PART OF THE PENCIL CAME OFF EASILY. NOTHING FELL INTO THE PATIENT'S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9189334 ↗
• InjuryJul 24, 2018Break; Suction Problem; Dent in Material; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLEDOCHOLITHOTOMY, THE HANDSET AND THE ELECTRODE WERE USED, AND THOSE WERE REPEATEDLY IN AND OUT OF 5MM TROCAR. HOWEVER, SUCTION WAS SUDDENLY DISABLED. THE SHAFT WAS CHECKED AND IT WAS FOUND DAMAGED ABOUT 2CM OF THE SHAFT NEXT TO L HOOK ELECTRODE. NEW DEVICE WAS USED, BUT THEN THE ELECTRODE HAD DENT UPON RETRACTING, AND LIVER WAS DAMAGED. NOTHING FELL INTO PATIENT'S CAVITY. OOZING BLEEDING LESS THAN 200CC, NO TRANSFUSION WAS NECESSARY. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding; Tissue Damage

  MAUDE report 7713610 ↗
• MalfunctionMay 30, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE DEVICE WAS USED AS INDICATED BUT THE SHAFT DISENGAGED FROM THE PENCIL GRIP. THE SHAFT WAS CONNECTED TO THE GRIP BUT EASILY DISENGAGED. A NEW PENCIL GRIP WAS USED TO CONTINUE. THERE WAS NO PATIENT HARM. NOTHING FELL INTO THE PATIENT CAVITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6598921 ↗
• MalfunctionMar 17, 2017Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, WHEN COAG WAS ACTIVATED THE BUTTON DID NOT RETURN SMOOTHLY. A NEW DEVICE WAS OPENED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6414649 ↗
• MalfunctionDec 15, 2016Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT THE ACTIVATION BUTTON KEEPS STICKING ON THE HANDSET. THERE WAS NO INJURY TO THE PATIENT. THE ISSUE WAS SOLVED BY USING A NEW DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6178956 ↗
• MalfunctionDec 15, 2016Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT THE ACTIVATION BUTTON KEEPS STICKING ON THE HANDSET. THERE WAS NO INJURY TO THE PATIENT. THE ISSUE WAS SOLVED BY USING A NEW DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6178832 ↗
• MalfunctionNov 7, 2016Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE CUT AND COAG BUTTONS DID NOT RETURN TO OFF POSITION AFTER BEING PRESSED. THE DEVICE KEPT ACTIVATING. THE WAS NO HARM TO THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6083264 ↗
• MalfunctionNov 3, 2016Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT DURING A TOTAL LAPAROSCOPIC COLECTOMY PROCEDURE, THE COAG BUTTON DID NOT RETURN TO THE OFF POSITION. THERE WAS NO PATIENT HARM. A NEW DEVICE WAS OPENED TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6076868 ↗
• MalfunctionSep 29, 2016Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT PRIOR TO THE START OF THE PROCEDURE, THE COAG BUTTON DID NOT RETURN ONCE BEING PRESSED. THERE WAS NO PATIENT INVOLVEMENT. A NEW DEVICE WAS OPENED TO CONTINUE.

  Patient problems: No Patient Involvement

  MAUDE report 5987164 ↗
• MalfunctionSep 22, 2016Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, THE COAG BUTTON WAS STIFF AND THE DEVICE DID NOT ACTIVATE BY PRESSING THE BUTTON. THERE WAS NO PATIENT INVOLVEMENT. A NEW DEVICE WAS USED TO CONTINUE. INITIAL EVALUATION BY MEDTRONIC FOUND THE PENCIL TO INTERMITTENTLY LATCH ON IN THE COAG MODE WHEN THE ROCKER SWITCH WAS PRESSED.

  Patient problems: No Patient Involvement

  MAUDE report 5971196 ↗
• MalfunctionSep 14, 2016Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT PRIOR TO USE THE COAG SWITCH WAS STIFF AND IT DID NOT RETURN ONCE BEING PRESSED. THE DEVICE DID NOT STOP ACTIVATING. THERE WAS NO PATIENT INVOLVEMENT. A NEW DEVICE WAS USED FOR THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 5951140 ↗
• MalfunctionAug 23, 2016Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE COAG BUTTON DID NOT RETURN ONCE IT WAS PRESSED AND ACTIVATION CONTINUED. THE BUTTON WAS PRESSED SEVERAL TIMES BUT THE ISSUE WAS NOT SOLVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5896134 ↗
• MalfunctionJun 28, 2016Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT DISENGAGE AND WAS STUCK IN THE ON POSITION. AFTER CHANGING OUT THE HANDPIECE THE ISSUE WAS CORRECTED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5755035 ↗