ROBI 38610MDRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04048551328682), received between May 9, 2019 and Sep 10, 2026 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Sparking” (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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Arcing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722717 ↗
• MalfunctionMay 22, 2026Sparking

  IT WAS REPORTED THAT "THE ROBI FORCEPS WAS SPARKING DURING SURGERY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR:--9610617-2026-01157. CROSS REFERENCE MDR:--9610617-2026-01158

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260536 ↗
• MalfunctionMay 18, 2026Sparking

  IT WAS REPORTED THAT THE PRODUCT SPARKS DURING TESTIN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210443 ↗
• MalfunctionMay 12, 2026Break

  THE CUSTOMER DID NOT PROVIDE A DETAILED DEFECT DESCRIPTION, IT WAS ONLY STATED "BROKEN". DURING THE INSPECTION IT WAS OBSERVED THAT THE JAW PART OF THE DEVICE IS THERMALLY DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151091 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE TWO STORZ BIPOLAR FORCEPS BROKE ALLEGEDLY DUE TO MATERIAL FATIGUE. IT APPEARS TO BE A DEFECTIVE BATCH. THE FRACTURE OCCURRED WHEN HIGH-FREQUENCY / ELECTROSURGERY WAS APPLIED. A REPLACEMENT INSTRUMENT WAS USED, WHICH HAS ALSO BROKEN. THE SURGERY WAS PROLONGED BUT THERE WERE NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR 9610617-2026-00887.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957541 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE TWO STORZ BIPOLAR FORCEPS BROKE ALLEGEDLY DUE TO MATERIAL FATIGUE. IT APPEARS TO BE A DEFECTIVE BATCH. THE FRACTURE OCCURRED WHEN HIGH-FREQUENCY/ELECTROSURGERY WAS APPLIED. A REPLACEMENT INSTRUMENT WAS USED, WHICH HAS ALSO BROKEN. THE SURGERY WAS PROLONGED BUT THERE WERE NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR 9610617-2026-00888.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957480 ↗
• MalfunctionApr 2, 2026Sparking

  IT WAS REPORTED THAT THE FORCEPS WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. DURING USE, THE DEVICE EMITTED SMOKE AND SPARKS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769766 ↗
• MalfunctionMar 2, 2026Sparking

  THE FOLLOWING WAS REPORTED: "A FLAME APPEARED AT THE TIP OF THE INSERT DURING A SURGICAL PROCEDURE (HYSTEROSCOPY UNDER LAPAROSCOPY), PERFORMED BY DR, A ROBI STORZ FORCEPS WAS USED DURING THE FINAL HEMOSTASIS PHASE. THE INSTRUMENT WAS NON FUNCTIONAL FROM THE MOMENT IT WAS FIRST ACTIVATED, AND GREEN LIGHTS APPEARED AT THE TIP OF THE FORCEPS ON THE VIDEO TOWER MONITOR. THE ROBI FORCEPS WAS IMMEDIATELY REMOVED FROM THE TROCAR. A VISUAL INSPECTION OF THE INSTRUMENT SHOWED NO APPARENT ABNORMALITIES. THE FORCEPS WAS THEN TESTED OUTSIDE THE OPERATIVE FIELD BY PRESSING THE GENERATOR PEDAL: A FLAME APPEARED AT THE TIP OF THE INSERT, AND SIGNIFICANT TRACES OF MELTED AND BLACKENED PLASTIC WERE VISIBLE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491915 ↗
• MalfunctionJan 28, 2026Sparking

  IT WAS REPORTED THAT THE HANDLE MAKES NOISE DURING COAGULATION, AND SPARKS ARE COMING OUT OF THE PATIENT-SIDE INSERT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205639 ↗
• MalfunctionDec 19, 2025Smoking; Sparking; Smoking; Sparking

  IT WAS REPORTED THAT THE TOOL GENERATED SMOKE AND A SPARK WAS CREATED IN THE DISTAL PART AT FIRST USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-02375.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858123 ↗
• MalfunctionDec 19, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING LAPAROSCOPIC SURGERY FOR AN OVARIAN CYST, THE SURGICAL TEAM NOTICED THAT THE KARL STORZ ROBI BIPOLAR LAPAROSCOPIC GRASPING FORCEPS BEGAN TO HEAT UP ABNORMALLY AND TURNED BRIGHT RED, EMITTING SMOKE FROM THE JAWS' HOLDING SHAFT WHEN THE SCALPEL WAS ACTIVATED. THE PROBLEM WAS DETECTED IN THE PATIENT'S ABDOMEN AND REPRODUCED OUTSIDE THE ABDOMEN ON THE SURGICAL FIELD. THE FORCEPS WERE REPAIRED AND USED WITH THE CORRECT PROGRAM (SPECIFIC PROGRAM FOR ROBI HANDLES) ON THE ERBE VIO3 SN (B)(6) SCALPEL, CONNECTED TO THE BIPOLAR - BI SOCKET. IT WAS CONFIRMED THAT THERE WAS NO HARM CAUSED TO THE PATIENT, PRACTITIONER OR A THIRD PARTY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851367 ↗
• MalfunctionDec 16, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE BIPOLAR FORCEPS MALFUNCTIONED, FAILING TO PERFORM COAGULATION EFFECTIVELY. THE DEVICE SUDDENLY STOPPED WORKING, EVEN AFTER CHECKING THE CONNECTION TO THE ELECTROSURGICAL UNIT AND ATTEMPTING TO RESTART IT. IT WAS NECESSARY TO REPLACE IT WITH ANOTHER BIPOLAR FORCEPS TO CONTINUE THE SURGERY WITHOUT COMPROMISING THE PROCEDURE. THE FAILURE CONSISTED OF A COMPLETE INTERRUPTION OF THE COAGULATION FUNCTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-01560, 9610617-2025-02342.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823640 ↗
• MalfunctionDec 16, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE BIPOLAR FORCEPS MALFUNCTIONED, FAILING TO PERFORM COAGULATION EFFECTIVELY. THE DEVICE SUDDENLY STOPPED WORKING, EVEN AFTER CHECKING THE CONNECTION TO THE ELECTROSURGICAL UNIT AND ATTEMPTING TO RESTART IT. IT WAS NECESSARY TO REPLACE IT WITH ANOTHER BIPOLAR FORCEPS TO CONTINUE THE SURGERY WITHOUT COMPROMISING THE PROCEDURE. THE FAILURE CONSISTED OF A COMPLETE INTERRUPTION OF THE COAGULATION FUNCTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-01560, 9610617-2025-02343.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823596 ↗
• MalfunctionSep 8, 2025Electrical /Electronic Property Problem; Failure to Deliver Energy; Electrical /Electronic Property Problem; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE BIPOLAR FORCEPS MALFUNCTIONED, FAILING TO PERFORM COAGULATION EFFECTIVELY. THE DEVICE SUDDENLY STOPPED WORKING, EVEN AFTER CHECKING THE CONNECTION TO THE ELECTROSURGICAL UNIT AND ATTEMPTING TO RESTART IT. IT WAS NECESSARY TO REPLACE IT WITH ANOTHER BIPOLAR FORCEPS TO CONTINUE THE SURGERY WITHOUT COMPROMISING THE PROCEDURE. THE FAILURE CONSISTED OF A COMPLETE INTERRUPTION OF THE COAGULATION FUNCTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994143 ↗
• MalfunctionJun 18, 2025Smoking; Temperature Problem; Smoking; Temperature Problem

  IT WAS REPORTED THAT "DURING A UROLOGY PROCEDURE, WE EXPERIENCED A MALFUNCTION WITH THE ROBI FORCEPS - IT BEGAN TO EMIT A SIGNIFICANT AMOUNT OF SMOKE INSIDE THE PATIENT'S ABDOMEN". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287484 ↗
• InjuryJun 6, 2025Electrical /Electronic Property Problem; Sparking; Electrical /Electronic Property Problem; Sparking

  IT WAS REPORTED THAT DURING THE PROCEDURE, INSIDE THE PATIENT'S CAVITY, THE ROBI FORCEPS MALFUNCTIONED. THE CLIENT REPORTS THAT THE SCALPEL MODEL USED WITH THE FORCEPS WAS THE WEM SS-501SX. NO NEGATIVE IMPACT ON THE PROCEDURE AND IN STATE OF HEALTH REPORTED. ON MAY 29, 2025 ADDITIONAL INFORMATION WAS RECEIVED: THE ROBI FORCEPS SPARKED IN THE PATIENT'S ABDOMINAL CAVITY DURING A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ROBI FORCEPS HAD TO BE REPLACED AND CLINICAL ENGINEERING WAS CALLED. THEREFORE, THE PROCEDURE WAS PROLONGED BETWEEN 15 AND 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159995 ↗
• InjuryJun 6, 2025Sparking; Sparking

  IT WAS REPORTED THAT DURING THE PROCEDURE, INSIDE THE PATIENT'S CAVITY, THE ROBI FORCEPS MALFUNCTIONED. THE CLIENT REPORTS THAT THE SCALPEL MODEL USED WITH THE FORCEPS WAS THE WEM SS-501SX. NO NEGATIVE IMPACT ON THE PROCEDURE AND IN STATE OF HEALTH REPORTED. ON MAY 29, 2025 ADDITIONAL INFORMATION WAS RECEIVED: THE ROBI FORCEPS SPARKED IN THE PATIENT'S ABDOMINAL CAVITY DURING A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ROBI FORCEPS HAD TO BE REPLACED AND CLINICAL ENGINEERING WAS CALLED. THEREFORE, THE PROCEDURE WAS PROLONGED BETWEEN 15 AND 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159994 ↗
• MalfunctionApr 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS ONLY REPORTED THAT THE INSTRUMENT IS "BROKEN". THE INTERNAL ASSESSMENT REVEALED THAT THE JAW PART IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21901878 ↗
• MalfunctionApr 22, 2025Electrical /Electronic Property Problem; Sparking; Electrical /Electronic Property Problem; Sparking

  IT WAS REPORTED THAT "THE ROBI FORCEPS FROM THE COELIO BOX PRODUCED SPARKS DURING THE TEST ON A GAUZE PAD SOAKED IN RED BETADINE AND SALINE SOLUTION, PRIOR TO THE INCISION USING A COVIDIEN BRAND BIPOLAR GENERATOR, SET TO 30 WITH A FOOT PEDAL." IT WAS INDICATED THAT THE ISSUE WAS DETECTED PRIOR TO MEDICAL PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

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

  MAUDE report 21883963 ↗
• MalfunctionMar 6, 2025Sparking; Temperature Problem; Device Handling Problem; Sparking; Temperature Problem; Device Handling Problem

  IT WAS REPORTED DURING A LAPAROSCOPIC APPENDECTOMY, THE BIPOLAR DISSECTOR FORCEPS EMITTED A SPARK AFTER A FEW MINUTES OF USE, CAUSING THE PLASTIC AROUND THE HEAD FIXATION SCREW TO MELT. THE SURGEON IMMEDIATELY STOPPED USING THE INSTRUMENT AS SOON AS THE SPARK APPEARED. NO SURGICAL DELAY OR PROLONGATION OF SURGERY REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21542237 ↗
• MalfunctionOct 9, 2024Temperature Problem; Device Handling Problem; Temperature Problem; Device Handling Problem

  IT WAS REPORTED THAT DURING THE SURGERY, WHILE COAGULATING, THE FORCEPS EMITTED A SPARK IN THE INSERT INSIDE THE PATIENT (ABDOMINAL CAVITY). NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. A REPORT WILL BE SENT OUT AS PRECAUTIONARY MEASURE DUE TO THE SPARK INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412529 ↗
• MalfunctionAug 5, 2024Electrical /Electronic Property Problem; Temperature Problem; Electrical /Electronic Property Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, ITEM SPARKED INSIDE OF PATIENT. THERE WAS NO ONE FROM KARL STORZ TO WITNESSED THIS. MANAGER, ONSITE ENDOSCOPY BELIEVES IT IS THE INSERT, AND WOULD LIKE ALL THREE ITEMS EVALUATED TOGETHER. FEMALE PATIENT NOT HARMED, CASE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912013 ↗
• MalfunctionJul 10, 2024Electrical /Electronic Property Problem; Fire; Electrical /Electronic Property Problem; Fire

  IT WAS REPORTED THAT AFTER THE PNEUMOPERITONEUM WAS ESTABLISHED WITH CO2 AT THE BEGINNING OF THE PROCEDURE, A MALFUNCTION OCCURRED WHILE USING THE FORCEPS AS IT EMITTED A FLAME. THE EQUIPMENT WAS IMMEDIATELY REMOVED FROM THE PATIENT AND SIMULTANEOUSLY DISCONNECTED." THERE IS NO INFORMATION ABOUT PATIENT HARM. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19711686 ↗
• InjuryJul 8, 2024Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT THE USE OF A ROBI CLAMP CAUSED TACHYCARDIA IN A PATIENT. THE SURGEON SUSPECTS THAT THESE ARRHYTHMIAS ARE DUE TO A LOSS OF SEAL IN THE CLAMP, WHICH MAY BE ALLOWING CURRENT TO PASS THROUGH.

  Patient problems: Tachycardia

  MAUDE report 19691901 ↗
• InjuryJul 8, 2024Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT THE USE OF A ROBI CLAMP CAUSED TACHYCARDIA IN A PATIENT. THE SURGEON SUSPECTS THAT THESE ARRHYTHMIAS ARE DUE TO A LOSS OF SEAL IN THE CLAMP, WHICH MAY BE ALLOWING CURRENT TO PASS THROUGH.

  Patient problems: Tachycardia

  MAUDE report 19691863 ↗