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

Model Number	38610ML
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the item sprays sparks during procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the customer was also unable to provide any further details.However, it is important to note that at no time were patients, users, or third parties harmed, and there was no impact on operational procedures.There were no delays, medical consequences, or additional hospital stays.The visual and functional inspection revealed significant thermal damage to the distal end and the shaft.The cause was identified as a short circuit in the area of the fork, which led to local overheating and the melting of plastic.The high-voltage test of the entire test batch was unremarkable; all measured values were within specifications.Two additional reported items could not be evaluated due to a lack of information.The nature of the damage does not indicate a material or manufacturing defect, but rather points predominantly to an operating error, particularly due to residual moisture following incomplete drying or failure to adhere to parameter settings.As a preventive measure, strict adherence to the operating instructions, training of operating personnel, and regular visual inspections are recommended.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 24202965
• Report Number: 9610617-2026-00141
• Device Sequence Number: 18605605
• Product Code: GEI
• UDI-Device Identifier: 04048551328675
• UDI-Public: 04048551328675
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 38610ML
• Device Catalogue Number: 38610ML
• Device Lot Number: TL04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.; UNKNOWN.
• Patient Sex: Unknown