ROBIRecalls & reported problems across all models
Karl Storz GmbH & Co. KG · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 10 models of ROBI by Karl Storz GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Jul 21, 2017 and Sep 10, 2026 — classified as 18 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Sparking” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ROBI problems
Device problems
- Sparking24
- Electrical /Electronic Property Problem14
- Temperature Problem12
- Energy Output Problem9
- Break8
- Detachment of Device or Device Component6
- Overheating of Device6
- Smoking6
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- Insufficient Information12
- No Consequences Or Impact To Patient5
- Foreign Body In Patient3
- Tachycardia2
- Patient Problem/Medical Problem1
ROBI models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ROBI 38610MDELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES29 reports
- ROBI 38610ONELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES18 reports
- ROBI 38600ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES12 reports
- ROBI 38151ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES7 reports
- ROBI 38610MLELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- ROBI 38610MWELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- ROBI 38710ONELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- ROBI 38610MAELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- ROBI 38310MDELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- ROBI 38910MDELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent ROBI adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionAug 6, 2026Fracture
It was reported that damaged after approximately 3 months of use. Plastic hinge part chipped. Two cracks confirmed at insert hinge area. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164332 ↗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 ↗InjuryJun 30, 2026No Display/Image
IT WAS REPORTED THAT THE FORCEPS SCREW FELL INTO THE PATIENT. TO LOCATE THE SCREW, X-RAYS WERE TAKEN.
Patient problems: Insufficient Information
MAUDE report 25668590 ↗InjuryJun 30, 2026No Display/Image
IT WAS REPORTED THAT THE FORCEPS SCREW FELL INTO THE PATIENT. TO LOCATE THE SCREW, X-RAYS WERE TAKEN.
Patient problems: Insufficient Information
MAUDE report 25668094 ↗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 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 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 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 ↗
Other Karl Storz GmbH & Co. KG products
All Karl Storz GmbH & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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