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

Model Number	38610MD
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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 use of a robi clamp caused tachycardia in a patient.The surgeon suspects that these arrhythmias are due to a loss of seal in the clamp, which may be allowing current to pass through.
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
When using the robi set with the associated generator, muscle contractions can occur due to the current flow, which are transmitted, for example, by the 38610md forceps insert (contact with the body).Reference is made to this point in the ifu of the autocon.In hf surgical applications (especially applications in which an electric arc is formed), part of the hf current is converted into a low-frequency current.This can trigger muscle contractions in the patient.Internal karl storz reference number: (b)(4).

• Brand Name: ROBI KELLY FORCEPS INSERT
• Common Device Name: RIGID FORCEPS
• 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: 19691901
• Report Number: 9610617-2024-00203
• Device Sequence Number: 7156483
• Product Code: GEI
• UDI-Device Identifier: 04048551328682
• UDI-Public: 4048551328682
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2024

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: 38610MD
• Device Catalogue Number: 38610MD
• Device Lot Number: PL47
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 07/30/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/25/2024; 08/01/2024
• 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