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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION AHTO; EVACUATOR, GASTRO-UROLOGY

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STRYKER CORPORATION AHTO; EVACUATOR, GASTRO-UROLOGY Back to Search Results
Model Number 0250070600
Device Problem Material Discolored (1170)
Patient Problem No Patient Involvement (2645)
Event Date 01/31/2020
Event Type  malfunction  
Event Description
When we opened the package, the tubing inside was brown instead of clear.We did not place it on the sterile back table.We obtained another irrigation set.There was no patient involvement, and it happened before the patient got into the room and while we were opening up for the case.
 
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Brand Name
AHTO
Type of Device
EVACUATOR, GASTRO-UROLOGY
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical court
san jose CA 95138
MDR Report Key9792382
MDR Text Key182165317
Report Number9792382
Device Sequence Number1
Product Code KQT
UDI-Device Identifier07613327061499
UDI-Public(01)07613327061499(17)200919(10)18263FG2
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number0250070600
Device Catalogue Number250-070-600
Device Lot Number18263FG2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2020
Event Location Hospital
Date Report to Manufacturer03/05/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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