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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC
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STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC Back to Search Results
Catalog Number P2000
Device Problems Display or Visual Feedback Problem (1184); Misconnection (1399); Insufficient Flow or Under Infusion (2182); Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2022
Event Type  Injury  
Event Description
It was reported that the thermedx tubing was incorrectly attached to a scope, which caused low fluid flow.Due to the low flow the surgeon had trouble with visualization and the patient's surgery was aborted.The patient had to return for a follow up surgery.
 
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 Description
It was reported that the thermedx tubing was incorrectly attached to a scope, which caused low fluid flow.Due to the low flow the surgeon had trouble with visualization and the patient's surgery was aborted.The patient had to return for a follow up surgery.
 
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: loss of visualization.Probable root cause: incorrect canister change operation or incorrect use of fluid deficit monitoring the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.
 
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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
benjamin ly
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key15619599
MDR Text Key301909957
Report Number3007495879-2022-00008
Device Sequence Number1
Product Code HIG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/30/2022
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 NumberP2000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/22/2022
Initial Date FDA Received10/17/2022
Supplement Dates Manufacturer Received09/22/2022
Supplement Dates FDA Received11/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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