MAUDE Adverse Event Report: STRYKER CORPORATION STRYKEFLOW 2; APPARATUS, SUCTION, OPERATING-ROOM

Catalog Number 250-070-520

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 03/07/2018

Event Type  malfunction  

Event Description

The suction irrigator was leaking from the motorized base joint to the irrigation line.The saline was dripping out of that joint.A new unit was opened and utilized to complete the procedure.

• Brand Name: STRYKEFLOW 2
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 7372853
• MDR Text Key: 103551460
• Report Number: 7372853
• Device Sequence Number: 1
• 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: Other
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/22/2019
• Device Catalogue Number: 250-070-520
• Device Lot Number: 17356FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 96