MAUDE Adverse Event Report: STRYKER CORPORATION STRYKEFLOW; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 0250070520

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

The handle from a stryker irrigator was leaking when the irrigation button was pushed.

• Brand Name: STRYKEFLOW
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 18595041
• MDR Text Key: 333961807
• Report Number: 18595041
• Device Sequence Number: 1
• Product Code: GCX
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0250070520
• Device Catalogue Number: 250-070-520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Male