Valleylab E3783R-28ASPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521767829), received between Nov 11, 2022 and Mar 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Melted; Peeled/Delaminated; Smoking; Arcing; Melted; Peeled/Delaminated; Smoking; Arcing

  IT WAS REPORTED THAT DURING A TRANSANAL TOTAL MESORECTAL EXCISION (TATME), WHEN THE TWO GENERATORS OF THE ELECTRIC JACK WERE BEING USED AT THE SAME TIME, IT WAS DISCOVERED THAT THE ELECTRODES WERE BURNT AND MELTED ON THE ANUS SIDE. THE BLACK HEAT SHRINK WAS BURNT AND MELTED. IT SMELLED STRANGE, SMOKE FROM THE SMOKE EXTRACTION EQUIPMENT, IT WAS NOT NOTICED BECAUSE THE SMOKE WAS EMITTED IN THE SCOPE. NOTICED THAT A SPARK WAS GENERATED IN THE SHAFT THAT HIT THE ANAL SPHINCTER. WHEN THE ELECTRODE WAS CHECKED, A BROWN BURN HOLE WAS OPENED AND IT WAS MELTED. APPROXIMATELY 1-2 HOURS AFTER STARTING USE AT THIS POINT. A NEW PRODUCT WAS TAKEN OUT, BUT THE SAME PART THAT HIT THE SPHINCTER MELTED IMMEDIATELY, SO THE OTHER ELECTRODE WAS REPLACED WITH A NEW ONE, AND THE OPERATION WAS CONTINUED. THE OUTPUT OF THE ELECTROCAUTERY GENERATOR WAS NOT TOO HIGH; IT WAS USED IN CUT MODE WITH NORMAL OUTPUT; 1 OUTPUT TIME WAS NOT LONG; IT WAS RATHER SHORT BECAUSE IT WAS USED TO HOOK IT WITH A HOOK. IT WAS ALSO CONFIRMED EARLIER ABOUT THE POSSIBILITY THAT THE CURR ENT CIRCUIT OF THE ELECTROCAUTERY SCALPEL ITSELF MAY HAVE BLOWN, THE TECH SUPPORT SAID THAT WITH REGARD TO THE OUTPUT OF 2 ELECTROCAUTERY GENERAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712962 ↗
• MalfunctionMar 27, 2025Melted; Peeled/Delaminated; Smoking; Arcing; Melted; Peeled/Delaminated; Smoking; Arcing

  IT WAS REPORTED THAT DURING A TRANSANAL TOTAL MESORECTAL EXCISION (TATME), WHEN THE TWO GENERATORS OF THE ELECTRIC JACK WERE BEING USED AT THE SAME TIME, IT WAS DISCOVERED THAT THE ELECTRODES WERE BURNT AND MELTED ON THE ANUS SIDE. THE BLACK HEAT SHRINK WAS BURNT AND MELTED. IT SMELLED STRANGE, SMOKE FROM THE SMOKE EXTRACTION EQUIPMENT, IT WAS NOT NOTICED BECAUSE THE SMOKE WAS EMITTED IN THE SCOPE. NOTICED THAT A SPARK WAS GENERATED IN THE SHAFT THAT HIT THE ANAL SPHINCTER. WHEN THE ELECTRODE WAS CHECKED, A BROWN BURN HOLE WAS OPENED AND IT WAS MELTED. APPROXIMATELY 1-2 HOURS AFTER STARTING USE AT THIS POINT. A NEW PRODUCT WAS TAKEN OUT, BUT THE SAME PART THAT HIT THE SPHINCTER MELTED IMMEDIATELY, SO THE OTHER ELECTRODE WAS REPLACED WITH A NEW ONE, AND THE OPERATION WAS CONTINUED. THE OUTPUT OF THE ELECTROCAUTERY GENERATOR WAS NOT TOO HIGH; IT WAS USED IN CUT MODE WITH NORMAL OUTPUT; 1 OUTPUT TIME WAS NOT LONG; IT WAS RATHER SHORT BECAUSE IT WAS USED TO HOOK IT WITH A HOOK. IT WAS ALSO CONFIRMED EARLIER ABOUT THE POSSIBILITY THAT THE CURR ENT CIRCUIT OF THE ELECTROCAUTERY SCALPEL ITSELF MAY HAVE BLOWN, THE TECH SUPPORT SAID THAT WITH REGARD TO THE OUTPUT OF TWO ELECTROCAUTERY GENER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710722 ↗
• MalfunctionSep 11, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO REPORTER, DURING PROCEDURE, DEVICE HAD INSULATION ISSUE. THE TIP COVER MELTED AND IT ENERGIZED FROM THERE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195764 ↗
• MalfunctionAug 13, 2024Melted; Peeled/Delaminated; Arcing; Melted; Peeled/Delaminated; Arcing

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE PLASTIC OUTER SHEATH MELTED. L-HOOK ARCED ON THE SIDE OF THE DEVICE, AND IT MELTED THE INSULATION AND END OF THE SUCTION TIP WHEN THE SURGEON WAS ACTIVATING THE L-HOOK. A NEW L-HOOK WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972991 ↗
• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CHOLE, THE DEVICE L-HOOK SHEATH FELL IN TO THE PATIENT. THE SURGEON PICKED OUT OF THE PIECE FROM ABDOMINAL CAVITY WITH A GRASPER. THERE WAS NO BLEEDING, TISSUE DAMAGE AND EXTENDED PROCEDURE TO RETRIEVE THE DETACHED PIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561388 ↗
• 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 15784686 ↗