ROBI 38151Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551325209), received between May 3, 2023 and Apr 3, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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. 9610617-2026-00756.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783406 ↗
• 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 24781542 ↗
• 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 24781541 ↗
• MalfunctionApr 23, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A DEFECT. THE INTERNAL ASSESSMENT REVEALED THAT THE HANDLE IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21893613 ↗
• MalfunctionAug 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property 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 19912420 ↗
• MalfunctionJul 5, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT 38700 ROBI METAL OUTER SHEATH. ACCORDING TO THE INFORMATION RECEIVED THE DOCTOR STATED THAT AT THE BEGINNING OF THE PROCEDURE THE INSTRUMENTS MELTED AND BURNED WHEN THEY WERE USED WITH THE OLDER EQUIPMENT. THERE WAS NO PATIENT/USERT HARM/INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262399 ↗
• MalfunctionMay 3, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT 38151 ROBI PLASTIC HANDLE. ACCORDING TO THE INFORMATION RECEIVED THE DOCTOR WAS SHOCKED AND BURNED. THERE WAS NO PATIENT HARM/INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859939 ↗