ROBI 38600Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04048551328606), received between Nov 28, 2020 and Apr 3, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Energy Output Problem

  IT WAS REPORTED THAT THE FORCEPS ARE NON-FUNCTIONAL, NO COAGULATION. THEY WERE DISASSEMBLED AND REASSEMBLED STILL NOT WORKING. AFTER REPLACING THE FORCEPS, THE SYSTEM WORKS WITHOUT ANY ISSUE, WITH NO CABLE CHANGE. THE PROCEDURE WAS COMPLETED AFTER REPLACING WITH FEW MINUTES DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781557 ↗
• MalfunctionApr 3, 2026Energy Output Problem

  IT WAS REPORTED THAT THE FORCEPS ARE NON-FUNCTIONAL, NO COAGULATION. THEY WERE DISASSEMBLED AND REASSEMBLED STILL NOT WORKING. AFTER REPLACING THE FORCEPS, THE SYSTEM WORKS WITHOUT ANY ISSUE, WITH NO CABLE CHANGE. THE PROCEDURE WAS COMPLETED AFTER REPLACING WITH FEW MINUTES DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781539 ↗
• MalfunctionApr 3, 2026Energy Output Problem

  IT WAS REPORTED THAT THE FORCEPS ARE NON-FUNCTIONAL, NO COAGULATION. THEY WERE DISASSEMBLED AND REASSEMBLED STILL NOT WORKING. AFTER REPLACING THE FORCEPS, THE SYSTEM WORKS WITHOUT ANY ISSUE, WITH NO CABLE CHANGE. THE PROCEDURE WAS COMPLETED AFTER REPLACING WITH FEW MINUTES DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781538 ↗
• MalfunctionApr 3, 2026Display or Visual Feedback 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, 9610617-2026-00755, 9610617-2026-00757.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780584 ↗
• MalfunctionMar 13, 2026Smoking

  IT WAS REPORTED THAT DURING ACTIVATION OF THE STORTZ BIPOLAR FORCEPS, SMOKE WAS RELEASED AT THE JOINT OF THE INSERT JAWS. ABSENCE OF COAGULATION AT THE JAWS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596045 ↗
• MalfunctionFeb 26, 2026Break

  THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION ABOUT THE DEFECT OR MALFUNCTION. ACCORDING TO THE INVESTIGATION RESULTS: DISTAL LOOSENED CONNECTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00380.

  Patient problems: Insufficient Information

  MAUDE report 24464277 ↗
• MalfunctionFeb 4, 2026Sparking

  IT WAS REPORTED THAT THE FORCEPS WERE SPARKING AND SMOKING. INSULATION HAS SEPARATED FROM THE COLLAR WHERE IT GOES INTO THE HANDLE ON ALL ITEMS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257673 ↗
• MalfunctionFeb 4, 2026Sparking

  IT WAS REPORTED THAT THE FORCEPS WERE SPARKING AND SMOKING. INSULATION HAS SEPARATED FROM THE COLLAR WHERE IT GOES INTO THE HANDLE ON ALL ITEMS .NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257636 ↗
• MalfunctionApr 29, 2025Smoking; Use of Device Problem; Smoking; Use of Device Problem

  THE CUSTOMER REPORTED AN ISSUE WITH ONE OF THEIR BIPOLAR BURNERS PRIOR TO PROCEDURE. IT FUNCTIONED CORRECTLY WHEN TESTED ON A WET WIPE AND WAS PLACED IN A BAG READY FOR USE. HOWEVER, THE OPERATING ROOM NURSE NOTICED A BURNT SMELL AND REMOVED THE BURNER FROM THE BAG. UPON RETESTING, SMOKE EMERGED FROM THE END NEAR THE JAWS, AND THE BURNER SUBSEQUENTLY FAILED TO OPERATE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931272 ↗
• MalfunctionAug 5, 2024Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device 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 19912206 ↗
• InjuryAug 30, 2022Material Fragmentation; Material Fragmentation

  INFORMATION RECIVED BY KARL STORZ INDICATES THAT THE DEVICE'S SHEATH WAS SEEN TO HAVE A SMALL SECTION MISSING ON THE TIP AND IT WAS NOT KNOWN IF IT WAS INSIDE THE PATIENT. THERE WAS NO WAY TO KNOW IF THE MISSING PIECE WAS MISSING BEFORE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324428 ↗
• InjuryNov 28, 2020Material Integrity Problem; Material Integrity Problem

  ALLEGEDLY, THE PATIENT WAS UNDERGOING A HYSTERECTOMY PROCEDURE AND THE BURN WAS NOTICED BY DR. (B)(6) AT THE END OF THE PROCEDURE. THE INSTRUMENTS WERE NOT EXCHANGED OUT AND THE CASE WAS COMPLETED WITH NO TREATMENT NECESSARY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10915777 ↗