MAUDE Adverse Event Report: KARL STORZ SE & CO. KG S-PILOT

Model Number	UP501
Medical Device Problem Codes	Power Problem (3010); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Pulmonary Edema (2020); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/19/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "the initial checks were done, the s-pilot was working, intra-operatively power could not be established.A prolonged morcellation time was indicated.The whole procedure was prolonged more than 60 minutes.As consequence, further interventions were required (ct scan, x-ray and itu admission) and therefore additional hospitalization necessary.In addition, on (b)(6) 2025 the information was received that the patient has passed away.
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.Additional information was added in section b5 - confirmation was received on april 11, 2025, that the karl storz s-pilot device did not have any intervention with the reported patient event.Device evaluation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer "showing no power - during use" was confirmed.Based on the defects found during the technical inspection it is concluded that the most likely cause for the described error is "overcurrent".Subsequently, the integrated fuse applied on the mainboard blown.The is stating that the product can fail during use.The above investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Confirmation was received on april 11, 2025, that the karl storz s-pilot device did not have any intervention with the reported patient event.

• Brand Name: S-PILOT
• Common Device Name: S-PILOT
• 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: 21681389
• Report Number: 9610617-2025-00491
• Device Sequence Number: 9281799
• Product Code: GCX
• UDI-Device Identifier: 04048551354155
• UDI-Public: 04048551354155
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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): 04/17/2025

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: UP501
• Device Catalogue Number: UP501
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/17/2025
• 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; Death
• Patient Sex: Unknown