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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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 a robi forceps burned during the procedure, but the patient was not affected.However, the following was reported: "prolongation of surgery.The surgery was initially scheduled for 3 hours, but due to the event it was prolongated by 60 minutes.".
Additional Manufacturer Narrative
Result of investigation: the item sent in is a robi forceps insert (ref.38610on) that was submitted for technical inspection.Significant local melting of the plastic component was observed at the distal end of the instrument.This clearly indicates excessive heat generation.According to the instructions for use (doc.No.97000117, version 3.2 - 02/2020), robi instruments are intended exclusively for short-term coagulation at a maximum peak voltage of 150 vp.If this limit is exceeded - for example, due to excessive power levels or excessive activation times of the hf current thermal damage may occur in accordance with iec 60601-2-2 (3rd edition).The observed thermal discoloration, melting of the plastic, and partial material changes are typical consequences of overloading due to improper use of hf current.There are two possible scenarios for this: 1.Residual moisture in the joint area: if the instrument was not completely dried after reprocessing, residual moisture can cause a short circuit during use, resulting in heat generation and damage.2.Non-compliance with hf limits: exceeding the permissible peak voltage or activating the hf for too long can lead to overheating and cause the damage described.In both scenarios, there is a violation of the instructions for use and the reprocessing instructions.It must therefore be assumed that this is a user error.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
• 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: 22099083
• Report Number: 9610617-2025-00930
• Device Sequence Number: 8340340
• Product Code: GEI
• UDI-Device Identifier: 04048551328651
• UDI-Public: 04048551328651
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 38610ON
• Device Catalogue Number: 38610ON
• Device Lot Number: OM13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown