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

Model Number	38610ON
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Temperature Problem (3022)
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).
Additional Manufacturer Narrative
Device evaluation: the marks found on the contact wire, particularly the discoloration visible in the area of the inner weld seam, clearly indicate excessive heat generation during operation.In combination with the customer's confirmation that the robi instrument 38610on was used at effect level 5 on the erbe device, it is highly probable that the permissible peak voltage of 150 vp was exceeded.However, according to the instructions for use, robi® devices are designed exclusively for short-term coagulation of small bleeds in the range of max.150 vp.Exceeding this value, for example due to excessive power levels or excessive duration of the hf current, can lead to thermal damage to the instrument in accordance with iec 60601-2-2 (3rd edition).The observed thermal discoloration and melting of the distal plastic insert are typical signs of such thermal overload.The cause of the damage is therefore most likely due to an operating error resulting from incorrect device settings.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 09245
• MDR Report Key: 21769827
• Report Number: 9610617-2025-00498
• Device Sequence Number: 9748827
• 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,Followup
• Report Date (Section B): 05/09/2025

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: VM03
• 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: 06/15/2025
• Supplement Date Received by Manufacturer: 04/15/2025; 05/07/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/11/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (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