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

Catalog Number	P2000
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/08/2023
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 patient experienced minor complication of blood clots.There was no mention of any significant delay or tissue damage created by the transient development of blood clots in the irrigant.Once bladder irrigation flow was restored, the blood clots were reported to resolve.
Additional Manufacturer Narrative
Alleged failure: power shut off the failure identified in the investigation is inconsistent with the alleged failure.Probable root cause: device not plugged into a dedicated 20a outlet.Per ifu the p2000 requires a dedicated 20a outlet.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that patient experienced minor complication of blood clots.There was no mention of any significant delay or tissue damage created by the transient development of blood clots in the irrigant.Once bladder irrigation flow was restored, the blood clots were reported to resolve.

• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18279425
• Report Number: 3007495879-2023-00004
• Device Sequence Number: 6054852
• Product Code: HIG
• UDI-Device Identifier: 00860936000310
• UDI-Public: 00860936000310
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 01/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: P2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/02/2024
• 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