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

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.

• Brand Name: AHTO
• Type of Device: EVACUATOR, GASTRO-UROLOGY
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical court; san jose CA 95138
• MDR Report Key: 9792382
• MDR Text Key: 182165317
• Report Number: 9792382
• Device Sequence Number: 1
• Product Code: KQT
• UDI-Device Identifier: 07613327061499
• UDI-Public: (01)07613327061499(17)200919(10)18263FG2
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 0250070600
• Device Catalogue Number: 250-070-600
• Device Lot Number: 18263FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1