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

Model Number	38610MD
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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
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.

• Brand Name: ROBI KELLY FORCEPS INSERT
• Common Device Name: ROBI KELLY FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22159994
• Report Number: 2020550-2025-00973
• Device Sequence Number: 7266135
• Product Code: GEI
• UDI-Device Identifier: 04048551328682
• UDI-Public: 04048551328682
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/06/2025
• Report Date (Section F): 06/06/2025

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: 38610MD
• Device Catalogue Number: 38610MD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2025
• 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: 38151,ROBI PLASTIC HANDLE; 38600, ROBI METAL OUTER SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown