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

Model Number	20016230
Medical Device Problem Codes	Circuit Failure (1089); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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 the urologist had finished enucleating the prostate and was about to use the morcellator but when testing the system, the foot pedal wouldn't allow the pinch value to open on the s-pilot.Procedure aborted and the patient will stay on the ward until the device is ready to use again.
Additional Manufacturer Narrative
Additional information was provided in section b5.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
On december 30, 2024 the information was received, that the patient has to wait for 2 weeks for another procedure.
Additional Manufacturer Narrative
Device evaluation: the device history records (dhr) have been checked and found to be according to the specification, valid at the time of production.During the system test investigation, it was determined that a malfunction occurs in the application when the connection cable on the foot switch is moved close to the cable exit point.Due to the cable break at the exit point on the housing, safe control can no longer be guaranteed.The failure in the customer's application can therefore be clearly attributed to the foot switch.The broken conductor in the cable was most probable caused by frequent movement during use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ONE-PEDAL FOOTSWITCH, ANALOG, TWO-STAGE
• Common Device Name: FOOT-SWITCH, 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 90245
• MDR Report Key: 20926912
• Report Number: 9610617-2024-00512
• Device Sequence Number: 5043243
• Product Code: HIH
• UDI-Device Identifier: 04048551274613
• UDI-Public: 04048551274613
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K223520
• 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): 02/07/2025

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: 20016230
• Device Catalogue Number: 20016230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/30/2024; 01/29/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/09/2025; 02/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MATERIAL: 20701020-1; MATERIAL: UP501S2
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown