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

Catalog Number P2000

Device Problem Pressure Problem (3012)

Patient Problem Perforation (2001)

Event Date 01/05/2021

Event Type  Injury  

Event Description

It was reported that the device showed an over pressure error alarm and a patient's bladder was perforated during the procedure.The patient required a follow up procedure to repair their bladder.

Manufacturer Narrative

Alleged failure: over pressure alarm.Root cause: rma 902 was issued for the return of the device to thermedx for further evaluation.Upon further investigation and trouble shooting the device was performing as intended.There was no event log to review due to the event log being extracted improperly at the user facility.Richard wolf rep (b)(6)explained that it was communicated to her by the customer that there was a bladder perforation during the procedure and the pressure reading on screen was 500mmhg.Further investigation confirmed that turp procedure was used along with a ll002 tube set.Per the thermedx procedure settings specification spec-10012 below, the maximum pressure setting is 100mmhg with a flow rate of 1000 ml/min.Thermedx determined that the "500 mmhg" on screen was the flow rate of 500 ml/min.The device will not exceed 100mmhg in this procedure.The device will cut power to the motor if pressure exceeds this limit.There is a software that detects the pressure through two separate pressure sensors.There are two pressure sensors built in as a redundant safety measure in case one of the pressure sensors fail.If one of the of the pressure sensors failed, there would be a sensor error message presented on screen.Furthermore, if the software failed and both pressure sensors failed the final safety mitigation is the pressure relief valve on the tube set which would relief pressure if the device went over 100 mmhg.Four separate safety mitigation would have to fail for the device to go over 100 mmhg in a turp procedure.The device was functionally tested at thermedx on service order 0950 and found to be functioning as intended.The device is cleared to for use in the field.There is no evidence of an over pressure situation.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: kelsey barla ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15200012
• MDR Text Key: 297611145
• Report Number: 3007495879-2022-00003
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: P2000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 08/10/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male