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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART UROLOGY TUBE SET; INSUFFLATOR, HYSTEROSCOPIC

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STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART UROLOGY TUBE SET; INSUFFLATOR, HYSTEROSCOPIC Back to Search Results
Catalog Number LL0006
Device Problems Contamination (1120); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2023
Event Type  malfunction  
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 foreign material was found in the sterile packaging.There was no patient involvement and no reported adverse consequences.
 
Event Description
It was reported that foreign material was found in the sterile packaging.There was no patient involvement and no reported adverse consequences.
 
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: human hair was found.Probable root cause: environmental controls.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
 
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Brand Name
FLUIDSMART UROLOGY TUBE SET
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 Key17303023
MDR Text Key319253670
Report Number3007495879-2023-00003
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 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
Device Operator Health Professional
Device Catalogue NumberLL0006
Device Lot Number113919
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/14/2023
Initial Date FDA Received07/11/2023
Supplement Dates Manufacturer Received06/14/2023
Supplement Dates FDA Received01/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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