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

Model Number	20016230
Medical Device Problem Code	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.

• 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
• MDR Report Key: 20926939
• Report Number: 2020550-2024-00512
• Device Sequence Number: 12029128
• Product Code: HIH
• UDI-Device Identifier: 04048551274613
• UDI-Public: 04048551274613
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024
• Report Date (Section F): 12/13/2024

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: 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2024
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MATERIAL: 20701020-1.; MATERIAL: UP501S2.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown