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

Catalog Number 250-070-600

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 11/21/2017

Event Type  malfunction  

Event Description

There were blue spots & whitish areas inside the sterile package (questionable sterility).

• Brand Name: AHTO
• Type of Device: EVACUATOR, GASTRO-UROLOGY
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical court; san jose CA 95138
• MDR Report Key: 7244627
• MDR Text Key: 99312256
• Report Number: 7244627
• Device Sequence Number: 0
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 250-070-600
• Device Lot Number: 17287FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2018
• Type of Device Usage: N
• Patient Sequence Number: 1