MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ONE-PEDAL FOOTSWITCH, ANALOG, TWO-STAGE; ELECTRICAL

Model Number	20016230
Medical Device Problem Codes	Unintended Power Up (1162); Unintended Movement (3026)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
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
The event occurred in spain.It was reported that after enucleation with a laser, the morcellator had to be used.We made the connection just before entering the patient with the blade.The blade began to rotate without any drive.Finally, the doctor had to perform another procedure.Additional patient information is not available.
Additional Manufacturer Narrative
It was reported that the morcellator handpiece was activated without requesting it.The morcellator handpiece is a passive device without any possibility to activate itself.The activation will be requested via the foot pedal.Therefore, we concluded the foot pedal to be the root cause for this issue - so the leading article of this report was changed to the foot pedal.The foot pedal was sent back to karl storz tuttlingen for further investigations.During the technical inspection, it was determined that the connection pin of the foot pedal is bent.This can cause a short circuit that activates the handpiece at the moment the foot pedal is connected.Based on the given facts, we have attributed the cause to a user error.Section to reflect the correct product information and evaluation codes.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ONE-PEDAL FOOTSWITCH, ANALOG, TWO-STAGE
• Common Device Name: ELECTRICAL
• 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
• MDR Report Key: 16724378
• Report Number: 9610617-2023-00073
• Device Sequence Number: 5922041
• Product Code: GCJ
• UDI-Device Identifier: 04048551274613
• UDI-Public: 4048551274613
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K010346
• 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
• Report Date (Section B): 07/28/2023
• 2 Devices were Involved in the Event: 1 2

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: 20016230
• Device Catalogue Number: 20016230
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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: Required Intervention; Other
• Patient Sex: Unknown