MAUDE Adverse Event Report: KARL STORZ SE & CO. KG S-PILOT; ENDOSCOPIC PROCEDURE AIR/WATER VALVE, REUSABLE

Model Number	UP501
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2023
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
It was reported that the up501 did not work during the procedure.The procedure had to be aborted and was continued after two days.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal (b)(6) complaint id: (b)(4).
Additional Manufacturer Narrative
An endurance test was carried out over 8 hours during which the device was disconnected from the power supply every 2 minutes and then supplied with power again in order to cause the automatic opening and closing of the valve.The opening and closing of the valve was also tested for approximately one hour using the push button on the device and the foot switch.No irregularities could be detected.The described error could not be reproduced.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: S-PILOT
• Common Device Name: ENDOSCOPIC PROCEDURE AIR/WATER VALVE, REUSABLE
• 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 ; GM 90245
• MDR Report Key: 17298876
• Report Number: 9610617-2023-00155
• Device Sequence Number: 12528008
• Product Code: GCX
• UDI-Device Identifier: 04048551354155
• UDI-Public: 4048551354155
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2023

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: 06/26/2023
• Supplement Date Received by Manufacturer: 07/12/2023; 11/16/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/10/2023; 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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