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

Model Number	P2000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Airway Obstruction (1699); Distress (2329); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2022
Type of Reportable Event	Death
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 during a procedure the fluid management system bags were showing as empty.While trying to recalibrate the machine the patient became distressed and a staff member accidentally unplugged the machine.The anesthesiologist had trouble establishing an airway and the patient passed away.
Event or Problem Description
It was reported that during a procedure the fluid management system bags were showing as empty.While trying to recalibrate the machine the patient became distressed and a staff member accidentally unplugged the machine.The anesthesiologist had trouble establishing an airway and the patient passed away.
Additional Manufacturer Narrative
Multiple attempts were made to the facility to obtain further information regarding the patient's condition; however, the user facility did not respond.Upon consultation with the stryker clinical team, consisting of: a senior global medical director, a senior medical safety manager, and a clinical operations director it was determined that the device did not likely cause or contribute to the patient's death for the following reasons: the patient was undergoing a hysteroscopy procedure, which has a potential for respiratory distress and death by air embolism.The thermedx device uses saline, which is unlikely to cause an anaphylaxis reaction.The thermedx device does not use co2 gas, which eliminates the risk for an air embolism.Based on the information provided by the stryker clinical team it was determined that the death was likely caused by anaphylaxis caused by anesthesia or another medication used during surgery, or caused by a venous gas embolism due to the risks associated with the hysteroscopy procedure.

• 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: kelsey barla ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14877463
• Report Number: 3007495879-2022-00001
• Device Sequence Number: 19330213
• Product Code: HIG
• UDI-Device Identifier: 00860936000310
• UDI-Public: 00860936000310
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K091939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: P2000
• 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): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2019
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown