Valleylab E3781R-28ASPRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521767805), received between Jan 19, 2021 and Sep 3, 2025 — classified as 8 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Arcing” (19 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE SCRUB NURSE WAS CLEANING THE ELECTRODE TIP PART OF THE DEVICE AND THE ELECTRODE TIP WAS COMPLETELY BROKEN OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949426 ↗
• MalfunctionAug 11, 2025Peeled/Delaminated; Arcing; Peeled/Delaminated; Arcing

  IT WAS REPORTED THAT SPARKS OCCURRED IN THE SHAFT PART OF ALL THREE DURING A ROBOTIC-ASSISTED RECTAL RESECTION, WHICH WAS PERFORMED AS A LAPAROSCOPIC SURGERY WITH ROBOT SUPPORT. THE EVENT TOOK PLACE DURING VASCULAR TREATMENT WITH OPTI4. THE ELECTRODES WERE REPLACED, AND THE PROCEDURE CONTINUED WITH A FOURTH ELECTRODE, WHICH FUNCTIONED NORMALLY. THE HANDLE WAS NOT REPLACED AND WAS DISCARDED WITHOUT BEING RECOGNIZED AS A DEFECTIVE PRODUCT. NO HEALTH DAMAGE OCCURRED, AND NO ADDITIONAL INTERVENTIONS OR PROCEDURES WERE REQUIRED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THE DEVICES HAD MELTING/BURN DAMAGE NEAR THE ASPIRATION HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770753 ↗
• MalfunctionAug 11, 2025Peeled/Delaminated; Arcing; Peeled/Delaminated; Arcing

  IT WAS REPORTED THAT SPARKS OCCURRED IN THE SHAFT PART OF ALL THREE DURING A ROBOTIC-ASSISTED RECTAL RESECTION, WHICH WAS PERFORMED AS A LAPAROSCOPIC SURGERY WITH ROBOT SUPPORT. THE EVENT TOOK PLACE DURING VASCULAR TREATMENT WITH OPTI4. THE ELECTRODES WERE REPLACED, AND THE PROCEDURE CONTINUED WITH A FOURTH ELECTRODE, WHICH FUNCTIONED NORMALLY. THE HANDLE WAS NOT REPLACED AND WAS DISCARDED WITHOUT BEING RECOGNIZED AS A DEFECTIVE PRODUCT. NO HEALTH DAMAGE OCCURRED, AND NO ADDITIONAL INTERVENTIONS OR PROCEDURES WERE REQUIRED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THE DEVICES HAD MELTING/BURN DAMAGE NEAR THE ASPIRATION HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770658 ↗
• MalfunctionAug 11, 2025Peeled/Delaminated; Arcing; Peeled/Delaminated; Arcing

  IT WAS REPORTED THAT SPARKS OCCURRED IN THE SHAFT PART OF ALL THREE DURING A ROBOTIC-ASSISTED RECTAL RESECTION, WHICH WAS PERFORMED AS A LAPAROSCOPIC SURGERY WITH ROBOT SUPPORT. THE EVENT TOOK PLACE DURING VASCULAR TREATMENT WITH OPTI4. THE ELECTRODES WERE REPLACED, AND THE PROCEDURE CONTINUED WITH A FOURTH ELECTRODE, WHICH FUNCTIONED NORMALLY. THE HANDLE WAS NOT REPLACED AND WAS DISCARDED WITHOUT BEING RECOGNIZED AS A DEFECTIVE PRODUCT. NO HEALTH DAMAGE OCCURRED, AND NO ADDITIONAL INTERVENTIONS OR PROCEDURES WERE REQUIRED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THE DEVICES HAD MELTING/BURN DAMAGE NEAR THE ASPIRATION HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770600 ↗
• MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLON RESECTION PROCEDURE, THE SPATULA'S PROXIMAL SIDE OF THE TIP (3 CM) WAS COMPLETELY DISENGAGED. THE BROKEN OPTI 4 TIP ELECTRODE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED BY PICKING IT UP WITH NO MEDICAL/SURGICAL INTERVENTION PERFORMED. NO INCIDENT CAUSED THE PROCEDURE TO BE EXTENDED BY MORE THAN 30 MINUTES. A NEW DEVICE WAS TAKEN OUT TO COMPLETE THE PROCEDURE. AFTER THE OPERATION, X-RAY WAS TAKEN AS A NORMAL PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299376 ↗
• MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER, THE BASE OF THE DEVICE FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT. IT WAS GRASPED WITH FORCEPS AND REMOVED/TAKEN OUT FROM THE BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297444 ↗
• MalfunctionApr 26, 2024Arcing; Detachment of Device or Device Component; Arcing; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE DEVICE GENERATED A LOT OF SPARKS WHEN USED IN THE ABDOMINAL CAVITY APP ROXIMATELY 5 HOURS AFTER THE START OF THE SURGERY. IT WAS BELIEVED THAT THE PROBLEM WAS CAUSED BY THE BURNING OF THE ESCHAR, BUT EVEN AFTER THE TIP WAS CLEANED, THE SPARKS SEEMED TO BE COMING FROM PART OF THE TUBE, ATTEMPT TO FIND THE RIGHT TIME TO REPLACE THE DEVICE WITH ANOTHER PRODUCT OF THE SAME MODEL NUMBER WAS URGED AND THE TIP GOT DAMAGED, THE DAMAGED PART WAS SHAKING AND DETACHED, IT WAS GRASPED WITH A FORCEPS AND REMOVED FROM THE ABDOMINAL CAVITY. NO X-RAY WAS PERFORMED TO LOCATE AND/OR RETRIEVE THE BROKEN PIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191473 ↗
• MalfunctionSep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, THE TIP OF THE DEVICE CAME OFF, THE PIECE DID NOT FALL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760837 ↗
• MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CARDIAC GASTRECTOMY, WHEN THE ELECTRODE INSERTION/REMOVAL WAS PERFORMED BY THE SCRUB NURSE, LINT CAME OUT FROM THE TIP AFTER CONNECTION BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. BECAUSE A FOREIGN OBJECT (LINT) CAME OUT, THIS PRODUCT WAS NOT USED, AND IT WAS REPLACED WITH ANOTHER DEVICE. AFTER THAT, IT WAS CONFIRMED THAT THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17598816 ↗
• MalfunctionMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINOPERINEAL RESECTION, ESCHAR ACCUMULATED AND THE AREA AROUND THE ASPIRATION HOLE MELTED. THE INSULATION WAS MELTED, SO A NEW PRODUCT WAS USED AND THE OPERATION WAS COMPLETED. NONE OF THE MELTED DEVICE FELL INTO THE PATIENT CAVITY NOR STICK TO THE PATIENT¿S TISSUE. THE INCIDENT DID NOT CAUSE THE PROCEDURE TO BE EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014458 ↗
• MalfunctionNov 11, 2022Melted; Peeled/Delaminated; Arcing; Adverse Event Without Identified Device or Use Problem; Melted; Peeled/Delaminated; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE DEVICE OUTER CYLINDER ON THE TIP SIDE WAS MELTED AND SPARKS APPEARED FROM THE MELTED HOLE DURING SURGERY. AT FIRST, SPARKS APPEARED 5 MINUTES AFTER USING THE HOOK. THE ELECTRODE WAS IMMEDIATELY REPLACED WITH A SPATULA-TYPE ONE, HOWEVER, A SPARK ALSO APPEARED DUE TO PROCTAL PROLAPSE, SO IT WAS REPLACED WITH A NEW SPATULA-TYPE AND USED. THERE WAS ALSO A INSULATOR PROBLEM TOTAL OF 3 SAMPLES SUBMITTED. THERE WAS NON SERIOUS INJURY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15784553 ↗
• MalfunctionNov 4, 2022Arcing; Detachment of Device or Device Component; Arcing; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN OUTPUTTING WITH AN ELECTROCAUTERY WHEN DEHISCENCE WAS PERFORMED AROUND THE RECTUM, A SPARK APPEARED FROM THE HOLE AT THE TIP OF THE DEVICE. NORMALLY, REPLACEMENT WAS PERFORMED, BUT WHEN IT WAS USED AS WAS, THE DEVICE BROKE OFF AND SEPARATED FROM THE ELECTRODE TIP ABOUT 2 CM FROM THE FRONT, SO IT COULD NO LONGER BE USED. A NEW ONE WAS USED, AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS. THE DOCTOR CONFIRMED THAT THE 1ST DEGREE UNINTENDED RECTAL WALL BURN FROM THE SPARKS WERE NOT TO THE EXTENT THAT RECOVERY WAS NECESSARY, AND NO PARTICULAR TREATMENT WAS PERFORMED. NO BROKEN PIECES FELL INTO THE BODY AND THE BROKEN ELECTRODE ITSELF WAS ALSO COLLECTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15724543 ↗
• InjuryOct 21, 2022Loose or Intermittent Connection; Detachment of Device or Device Component; Loose or Intermittent Connection; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR RECTAL RESECTION, THERE WAS INSUFFICIENT ADHESION. THE TIP OF THE CURVED SPATULA FELL INSIDE THE BODY. WHEN THE PRODUCT WAS USED AND ABOUT 4 HOURS HAD PASSED SINCE THE START OF THE OPERATION, THE TIP ALONG WITH THE BLACK PART THAT WELDED THE TIP FELL INTO THE BODY. THE DROPPED PRODUCT PARTS WERE COLLECTED IMMEDIATELY WHEN THEY WERE DROPPED INSIDE THE BODY. AFTER THE SURGERY, X-RAY WAS USED TO CHECK IF THERE WERE ANY REMAINING PARTS OUTSIDE THE BODY. TO BE SURE IF ALL PARTS HAVE BEEN RECOVERED AND THAT NO PARTS WERE MISSING.

  Patient problems: Foreign Body In Patient

  MAUDE report 15653520 ↗
• MalfunctionSep 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE ELECTRODE FOR LAPRO WAS INSERTED INTO THE ELECTRODE CONNECTION PART OF THE OPTI 4 HANDLE AND THE NUT WAS ROTATED BY THE CLOCKWISE TO FIX THE ELECTRODE AND USED, BUT WHEN THE ELECTRODE WAS PULLED A LITTLE, IT CAME OFF FROM THE CONNECTION PART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397936 ↗
• MalfunctionJul 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC UTERINE MYOMECTOMY, THE DEVICE WAS USED WITHOUT ANY PROBLEMS UNTIL THE MIDWAY OF THE PROCEDURE. THE SURGEON NOTICED THAT THE TIP OF THE ELECTRODE BROKE AND WAS MISSING WHEN THEY PULLED THE ELECTRODE IN AND PEELED IT OFF AND THEN PUSHED IT OUT AGAIN TRYING TO CUT INTO THE FIBROID. AFTER THAT, WHEN THE ABDOMINAL CAVITY WAS SEARCHED WITH A CAMERA, THE BROKEN TIP WAS FOUND AND REMOVED SAFELY WITH FORCEPS. ALL COMPONENTS WERE REMOVED FROM PATIENT'S CAVITY AND THERE WAS NO ADDITIONAL MEDICAL INTERVENTION PERFORMED DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059828 ↗
• MalfunctionApr 5, 2022Peeled/Delaminated; Arcing; Peeled/Delaminated; Arcing

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE AREA NEAR THE TIP OF THE NON MEDTRONIC ELECTRODE CANNULA WAS BURNED DURING THE SEPARATION OPERATION AROUND THE RECTUM. A SPARK FLEW TO THE SIDE WHEN IT WAS BEING CAUTERIZED USING A SPATULA, SO IT WAS DETERMINED TO BE DANGEROUS, AND IT WAS REPLACED WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015078 ↗
• MalfunctionMar 22, 2022Fire; Melted; Arcing; Fire; Melted; Arcing

  ACCORDING TO THE REPORTER, DURING ULTRA-LOW ANTERIOR RESECTION CASE, IT WAS OBSERVED ON THE MONITOR THAT A SPARK WAS EMITTED FROM THE BURNT PART OF THE SLEEVE, NOT THE TIP OF THE OPTI4 SPATULA TYPE ELECTRODE BY THE FIRST ONE AND SECOND ONE AFTER REPLACEMENT (LEFT A MELTED MARK). PROCEDURE WAS APPROACHED BY FORCE ENOUGH TO INSERT IT FROM THE TROCAR AND BENDED THE SHAFT OF THE OPTI4. IT WAS DISCHARGED NOT ONLY FROM THE SPATULA TYPE ELECTRODE PART OF THE TIP BUT ALSO FROM THE MELTED PART, SO IT WAS REPLACED WITH A NEW ONE. THE PATIENT TISSUE WAS NOT TOUCHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13850993 ↗
• MalfunctionMar 22, 2022Fire; Melted; Arcing; Fire; Melted; Arcing

  ACCORDING TO THE REPORTER, DURING ULTRA-LOW ANTERIOR RESECTION CASE, IT WAS OBSERVED ON THE MONITOR THAT A SPARK WAS EMITTED FROM THE BURNT PART OF THE SLEEVE, NOT THE TIP OF THE OPTI4 SPATULA TYPE ELECTRODE BY THE FIRST ONE AND SECOND ONE AFTER REPLACEMENT (LEFT A MELTED MARK). PROCEDURE WAS APPROACHED BY FORCE ENOUGH TO INSERT IT FROM THE TROCAR AND BENDED THE SHAFT OF THE OPTI4. IT WAS DISCHARGED NOT ONLY FROM THE SPATULA TYPE ELECTRODE PART OF THE TIP BUT ALSO FROM THE MELTED PART, SO IT WAS REPLACED WITH A NEW ONE. THE PATIENT TISSUE WAS NOT TOUCHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13850908 ↗
• MalfunctionFeb 15, 2022Difficult or Delayed Activation; Detachment of Device or Device Component; Intermittent Energy Output; Difficult or Delayed Activation; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE PENCIL AND THE CURVED SPATULA DEVICE COULD NOT ACTIVATE AS USUAL. IT WAS DIFFICULT TO ACTIVATE AND HAD AN INTERMITTENT ACTIVATION. AFTER CHANGING THE PENCIL TO A NEW ONE, THEY WERE ABLE TO USE IT WITH THE SAME GENERATOR WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE INSULATION ON THE TIP OF THE ELECTRODE HAD CHIPPED OFF AND THE PIECE NOT RETURNED. UPON FOLLOW-UP, IT WAS REPORTED THAT THE DEVICE WAS BROKEN DURING THE PROCEDURE, HOWEVER, IT DID NOT FELL INTO THE PATIENT'S CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534846 ↗
• MalfunctionFeb 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION PROCEDURE, THE ELECTRODE SUDDENLY BROKE AND WAS DROPPED INTO THE PATIENT'S ABDOMINAL CAVITY. ALL OF IT WAS COLLECTED AND REMOVED. ANOTHER PRODUCT WITH THE SAME PRODUCT NUMBER WAS USED, AND THE OPERATION WAS CONTINUED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454118 ↗
• MalfunctionJan 10, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, WHEN THE DEVICE WAS ACTIVATED AND BEING OPERATED, IT WAS NOTED THAT THE TISSUE THAT HAD COME IN CONTACT WITH THE TIP OF THE BLACK SHEATH, RATHER THAN THE ELECTRODE PART, WAS BURNED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206413 ↗
• MalfunctionNov 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, THE ELECTRODE SLIPPED OFF WHEN STRONG TENSION WAS APPLIED. THE PART FELL INTO THE PATIENT'S ABDOMINAL CAVITY BUT IT WAS REMOVED WITHOUT NEEDING AN X-RAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895219 ↗
• MalfunctionNov 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE ELECTRODE PORTION BROKE DURING ACTIVATION AND DROPPED INTO THE ABDOMINAL CAVITY. THE DROPPED OBJECT(S) WAS/WERE LARGE, SO ALL PARTS WERE RETRIEVED VISUALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827998 ↗
• MalfunctionSep 30, 2021Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD INSUFFICIENT ADHESION. INSULATION SHEATH CAME OFF FROM THE POINT OF USE. ANOTHER DEVICE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12557263 ↗
• MalfunctionAug 31, 2021Arcing; Electrical Shorting; Arcing; 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 12398066 ↗