ROBI 38610ONRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04048551328651), received between Sep 12, 2019 and Jul 31, 2026 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Sparking” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Sparking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104961 ↗
• MalfunctionJul 31, 2026Sparking

  It was reported that the Robi grasper sparked during procedure. No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104958 ↗
• MalfunctionApr 3, 2026Energy Output Problem

  IT WAS REPORTED THAT "BIPOLAR VIDEO LAPAROSCOPY FORCEPS DO NOT CONDUCT ELECTRICITY AND DO NOT COAGULATE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00748, 9610617-2026-00756, 9610617-2026-00757.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780471 ↗
• MalfunctionDec 19, 2025Smoking; Sparking; Smoking; Sparking

  NEW INFORMATION RECEIVED ON DECEMBER 19,2025 THE MALFUNCTION OCCURRED IN 2 SEPARATE PROCEDURES, PREVIOUSLY MENTIONED CROSS REFERENCED MDR IS NOT RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858124 ↗
• InjuryDec 16, 2025Break; Break

  ACCORDING TO THE INFORMATION RECEIVED, A FRACTURE AT THE BASE OF THE JAWS OF THE ROBI CLAMP WAS DISCOVERED DURING A PROCEDURE. THE DOCTOR STATES THAT IT TOOK OVER 30 MINUTES TO FIND A SIMILAR CLAMP. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821178 ↗
• MalfunctionDec 11, 2025Sparking; Sparking

  IT WAS REPORTED THAT THE SURGEON WAS USING ROBI INSTRUMENT AND IT WAS SPARKING INSIDE THE PATIENT DURING THE PROCEDURE. THE SET WAS TAKEN OUT OF CIRCULATION. THE CUSTOMER WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY AND NO ADDITIONAL INTERVENTIONS WERE NECESSARY. THERE WAS ONLY A SURGERY DELAY OF 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783426 ↗
• MalfunctionAug 8, 2025Electrical /Electronic Property Problem; Sparking; Temperature Problem; Electrical /Electronic Property Problem; Sparking; Temperature Problem

  IT WAS REPORTED THAT "DURING THE PROCEDURE, THE ROBI FORCEPS FAILED TO ENGAGE, RENDERING THE DEVICE UNABLE TO CUT OR COAGULATE TISSUE AS INTENDED. FOLLOWING THE INCIDENT, COMPANY REPRESENTATIVES INSPECTED THE INSTRUMENT IN THE HOSPITAL, WHERE VISIBLE SMOKE AND A SPARK WERE OBSERVED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755194 ↗
• InjuryJul 10, 2025Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED INTERMITTENT ISSUES - STOPPED WORKING (FIRST CASE (B)(4). DURING THE FIRST CASE THE SURGEON HAD INTERMITTENT ISSUES BUT MANAGED TO COMPLETE THE CASE. THE BIPOLAR STOPPED WORKING, THE LEAD HAD TO BE DISCONNECTED AND IT STARTED WORKING AGAIN. BUT THEN STOPPED AGAIN DURING ITS ACTION. HE MANAGED TO COMPETE THE CASE. THE DURATION OF THE PROLONGATION OF THE SURGERY WAS BETWEEN 15 AND 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. SINCE IT WAS REPORTED THERE WAS A PROLONGATION BETWEEN 15 AND 60 MINUTES, WHICH COULD BE MORE THAN 30 MINUTES, THIS CASE NEEDS TO BE REPORTED AS AN ADVERSE EVENT TO THE US FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470842 ↗
• InjuryJul 10, 2025Energy Output Problem; Energy Output Problem

  THE FOLLOWING WAS REPORTED INTERMITTENT ISSUES - STOPPED WORKING (FIRST CASE (B)(4). DURING THE FIRST CASE THE SURGEON HAD INTERMITTENT ISSUES, BUT MANAGED TO COMPLETE THE CASE. THE BIPOLAR STOPPED WORKING, THE LEAD HAD TO BE DISCONNECTED AND IT STARTED WORKING AGAIN. BUT THEN STOPPED AGAIN DURING ITS ACTION. HE MANAGED TO COMPETE THE CASE. THE DURATION OF THE PROLONGATION OF THE SURGERY WAS BETWEEN 15 AND 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. SINCE IT WAS REPORTED THERE WAS A PROLONGATION BETWEEN 15 AND 60 MINUTES, WHICH COULD BE MORE THAN 30 MINUTES, THIS CASE NEEDS TO BE REPORTED AS AN ADVERSE EVENT TO THE US FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470835 ↗
• MalfunctionJul 1, 2025Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED "SLIGHT INTERMITTENT ISSUES" (THIRD CASE (B)(4)). THE SOUND OF THE GENERATOR WAS LOWER PITCHED BUT THEN THEY HEARD A DEEP BEEPING SOUND WHERE THE BIPOLAR WOULD STOP WORKING MID COAGULATION. THE CASE WAS ABLE TO BE COMPLETED BUT WAS NOTED BY THE OPERATING SURGEON THAT IT STILL WAS INTERMITTENTLY WORKING. THE PROLONGATION OF THE CASE IS UNKNOWN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376726 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Device Handling Problem

  THE FOLLOWING WAS REPORTED "SIMILAR INTERMITTENT ISSUES AND THEN THE BIPOLAR FORCEPS WERE UNABLE TO STOP A BLEEDING (OOZE) ON THE LIVER FOLLOWING THE REMOVAL OF THE GALL BLADDER" (SECOND CASE (B)(4)). THE SURGEON TRIED FOR A GOOD FEW MINUTES BUT THE BLEEDING WOULD NOT STOP. THE SURGEON HAD TO USE "SURGICELL" AS WELL AS "FLOWSEAL" TO STOP THE BLEEDING ON THE LIVER AND THE PATIENT LOST ABOUT 50 ML OF BLOOD. THE CASE WAS ABLE TO BE COMPLETED FOLLOWING THE APPLICATION OF THE HAEMOSTASIS GEL. THE PROCEDURE WAS DELAYED BY ABOUT 30 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373658 ↗
• InjuryJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED "SIMILAR INTERMITTENT ISSUES AND THEN THE BIPOLAR FORCEPS WERE UNABLE TO STOP A BLEEDING (OOZE) ON THE LIVER FOLLOWING THE REMOVAL OF THE GALL BLADDER" (SECOND CASE (B)(4). THE SURGEON TRIED FOR A GOOD FEW MINUTES BUT THE BLEEDING WOULD NOT STOP. THE SURGEON HAD TO USE "SURGICELL" AS WELL AS "FLOWSEAL" TO STOP THE BLEEDING ON THE LIVER AND THE PATIENT LOST ABOUT 50 ML OF BLOOD. THE CASE WAS ABLE TO BE COMPLETED FOLLOWING THE APPLICATION OF THE HAEMOSTASIS GEL. THE PROCEDURE WAS DELAYED BY ABOUT 30 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372377 ↗
• InjuryMay 28, 2025Electrical /Electronic Property Problem; Overheating of Device; Temperature Problem; Electrical /Electronic Property Problem; Overheating of Device; Temperature Problem

  IT WAS REPORTED THAT A ROBI FORCEPS BURNED DURING THE PROCEDURE, BUT THE PATIENT WAS NOT AFFECTED. HOWEVER, THE FOLLOWING WAS REPORTED: "PROLONGATION OF SURGERY. THE SURGERY WAS INITIALLY SCHEDULED FOR 3 HOURS, BUT DUE TO THE EVENT IT WAS PROLONGATED BY 60 MINUTES."

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

  MAUDE report 22099083 ↗
• InjuryMay 28, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A ROBI FORCEPS BURNED DURING THE PROCEDURE, BUT THE PATIENT WAS NOT AFFECTED. HOWEVER, THE FOLLOWING WAS REPORTED: "PROLONGATION OF SURGERY. THE SURGERY WAS INITIALLY SCHEDULED FOR 3 HOURS, BUT DUE TO THE EVENT IT WAS PROLONGATED BY 60 MINUTES.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099040 ↗
• MalfunctionApr 3, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE INSTRUMENT STARTED BURNING IN THE LAPAROSCOPIC SURGERY. THERE ARE NO ADVERSE CONSEQUENCES, AND NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769853 ↗
• MalfunctionApr 3, 2025Electrical /Electronic Property Problem; Overheating of Device; Temperature Problem; Electrical /Electronic Property Problem; Overheating of Device; Temperature Problem

  IT WAS REPORTED THAT THE INSTRUMENT STARTED BURNING IN THE LAPAROSCOPIC SURGERY. THERE ARE NO ADVERSE CONSEQUENCES, AND NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769827 ↗
• MalfunctionFeb 5, 2025Sparking; Sparking

  ACCORDING TO THE INFORMATION RECEIVED, BURNT JAWS, INSERT STARTED TO SPARK. NO SURGICAL DELAY OR PROLONGATION OF SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY OR HARM. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314952 ↗
• MalfunctionSep 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE DOCTOR NOTICED THE INSTRUMENT DID NOT WORK AND FOUND THE ENTIRE DISTAL TIP OF THE FORCEPS FELL INTO THE PATIENT. THE LOOSE PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9010083 ↗