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

Catalog Number P2000

Device Problems Leak/Splash (1354); Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

It was reported that there was overpressure during procedure.

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.

Manufacturer Narrative

Alleged failure: cartridge/fluid leak.The failure identified in the investigation is consistent with the alleged failure.Probable root cause: device confirmed to have had a cartridge leak.The fluid leak caused the device to alarm with "i/o bus error" due to the ir temperature sensors being hit with fluid.Fluid in the device dried and cleared as intended.Cartridge weld failure which could most likely be caused by a material defect, user error, or a manufacturing issue.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

Event Description

It was reported that there was overpressure during procedure.

Event Description

It was reported that there was overpressure during procedure.

Manufacturer Narrative

Alleged failure: over pressure the failure identified in the investigation is inconsistent with the alleged failure.The issue could not be replicated.Device confirmed to have had a cartridge leak.The fluid leak caused the device to alarm with "i/o bus error" due to the ir temperature sensors being hit with fluid.Fluid in the device dried and cleared as intended.Probable root cause: cartridge weld failure which could most likely be caused by a material defect, user error, or a manufacturing issue.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: FLUIDSMART FLUID MANAGEMENT SYSTEM
• Type of Device: 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15635791
• MDR Text Key: 307155329
• Report Number: 3007495879-2022-00009
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: P2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 09/27/2022; 09/27/2022
• Supplement Dates FDA Received: 01/21/2023; 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1