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

Model Number UP501

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2023

Event Type  Injury  

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 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.

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).

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
• Type of Device: 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
• MDR Text Key: 318823484
• Report Number: 9610617-2023-00155
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 04048551354155
• UDI-Public: 4048551354155
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other