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

Model Number	38610ON
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the instrument started burning in the laparoscopic surgery.There are no adverse consequences, and no patient injury.The procedure was completed successfully.No negative impact in state of health reported.
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id:(b)(4).

• 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
• 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
• MDR Report Key: 21769853
• Report Number: 9610617-2025-00493
• Device Sequence Number: 18597353
• Product Code: GEI
• UDI-Device Identifier: 04048551328651
• UDI-Public: 04048551328651
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 38610ON
• Device Catalogue Number: 38610ON
• Device Lot Number: UN27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (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
• Patient Sex: Unknown