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

Model Number	38610MA
Medical Device Problem Codes	Sparking (2595); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the product did not perform as intended.During the first use of the robi forceps inserts, a spark occurred while the instruments were in use, causing the inserts to burn.Due to the burn damage, the insert cannot be removed from the outer tube".The procedure was successfully finished.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
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).
Additional Manufacturer Narrative
Correction in section d9 device was returned on june 16,2025.Device evaluation: since only item 38610ma was available for inspection, the assessment is based primarily on the information provided by the customer.The simultaneous damage to two different models from different batches during the same operation suggests an application error.Possible causes include residual moisture after processing, excessive operating voltage, incorrect device settings, or improper handling.The instructions for use explicitly state that failure to comply with the specifications provided therein may result in damage to the device.Therefore, it is highly likely that the damage was caused by improper use.According to the instructions for use (ifu), the medical device must be carefully inspected for any signs of damage prior to use.The ifu also warns that overloading the device or applying excessive force may result in breakage, bending, or malfunction.Such misuse can compromise the device's integrity and potentially affect its performance during medical procedures.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ROBI MALZONI FORCEPS INSERT
• Common Device Name: ROBI MALZONI 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: 21723162
• Report Number: 9610617-2025-00526
• Device Sequence Number: 19798779
• Product Code: GEI
• UDI-Device Identifier: 04048551328699
• UDI-Public: 04048551328699
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 10/22/2025

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: 38610MA
• Device Catalogue Number: 38610MA
• Device Lot Number: XL01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 10/17/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/23/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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