MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number	P2000
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was overpressure during procedure.
Event or Problem Description
It was reported that there was overpressure during procedure.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: too much pressure during a case probable root cause: incorrect procedure selection, or insufficient fluid pressure or flow, compromising visibility the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was overpressure during procedure.
Additional Manufacturer Narrative
The product was received at stryker endoscopy, usa.The investigation is as follows.Alleged failure: over pressure.The failure identified in the investigation is inconsistent with the alleged failure.Probable root cause: device was tested on the ureteroscopy procedure with pressure set to the 300mmhg set point limit.Eqp-0342 pressure gauge confirmed the pressure output from the device was within the set point pressure setting displayed on the device.Reviewing the event logs exported from the device had no confirmation of the device being used when the alleged failure occurred.Last shown use was on (b)(6) 2025.Zero pressure sensor and over temperature alarms were present in the event logs.Probable root cause is device presented an over pressure alarm due to cartridge removed while under pressure."a new cartridge must be installed in device.If a procedure has been started, use the end procedure button to return to setup screens, then press error message to dismiss.Proceed through screens to re-prime new cartridge." the reported failure mode will be monitored for future reoccurrence.

• Brand Name: FLUIDSMART FLUID MANAGEMENT SYSTEM
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21130826
• Report Number: 3007495879-2025-00001
• Device Sequence Number: 7582641
• Product Code: HIG
• UDI-Device Identifier: 00860936000310
• UDI-Public: 00860936000310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: P2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 03/10/2025; 09/26/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 04/08/2025; 10/15/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown