MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI FORCEPS INSERT

Model Number	38610ON
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
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.

• Brand Name: ROBI FORCEPS INSERT
• Common Device Name: ROBI FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22470835
• Report Number: 2020550-2025-01127
• Device Sequence Number: 14511709
• Product Code: GEI
• UDI-Device Identifier: 04048551328651
• UDI-Public: 04048551328651
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025
• Report Date (Section F): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 38610ON
• Device Catalogue Number: 38610ON
• Device Lot Number: RK08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/14/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 26176LV BIPOLAR HIGH FREQUENCY CORD, 300CM,; 38151 ROBI PLASTIC HANDLE LOT XL21.; 38600 ROBI METAL OUTER SHEATH, LOT UNKNOWN,
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown