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

Model Number	38610MD
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Sparking (2595)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that "the robi forceps from the coelio box produced sparks during the test on a gauze pad soaked in red betadine and saline solution, prior to the incision using a covidien brand bipolar generator, set to 30 with a foot pedal." it was indicated that the issue was detected prior to medical procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information was provided in section b5 and h6.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Further information was received on 18-apr-2025.According to the information the issue was identified during medical procedure, the procedure was completed successfully with a prolongation of less than 15 minutes and there were no adverse consequences for the patient.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation on may 2,2025.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
Result of investigation: during investigation of the returned products a short circuit/thermal damage was found at the distal end of product 38610md (robi kelly forceps insert).The nature of the damage indicates insufficient drying, which probably led to the damage.Based on the test results and comparison with unremarkable items from the same series it is concluded that this is a case of user error.It is concluded that the item was dried incorrectly or insufficiently after reprocessing, which led to a certain amount of residual moisture between the joints.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: 21883963
• Report Number: 9610617-2025-00657
• Device Sequence Number: 18167110
• Product Code: GEI
• UDI-Device Identifier: 04048551328682
• UDI-Public: 04048551328682
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/16/2026

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: 38610MD
• Device Catalogue Number: 38610MD
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 04/18/2025; 05/02/2025; 01/21/2026
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/02/2025; 05/22/2025; 02/16/2026
• 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: ARTICLE: 26176LV.LOT: YN01.; ARTICLE: 38151.LOT: YL31.; ARTICLE: 38600.LOT: TM02.
• Patient Sex: Unknown