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

Model Number	UP501
Medical Device Problem Codes	Mechanical Problem (1384); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: at the start of surgery, the pinch valve of the product remained open, and attempts to turn the power on and off did not improve the situation.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.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).
Additional Manufacturer Narrative
The device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, "pinch valve malfunction", could be confirmed.The cause of the error can be attributed to external fluid which entered the housing and caused the malfunction of the pinch valve.The additional determined issues shown in the product investigation tasks, are independent from the reported failure of the customer.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 event is filed under internal karl storz complaint id: (b)(4).

• 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
• MDR Report Key: 22730364
• Report Number: 9610617-2025-01381
• Device Sequence Number: 9143765
• Product Code: GCX
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/24/2026

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 08/12/2025; 06/12/2026
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 08/21/2025; 06/24/2026
• 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