MAUDE Adverse Event Report: STRYKER STRYKEFLOW SUCTION/IRRIGATOR; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number 250-070-520

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2017

Event Type  malfunction  

Event Description

Towards the end of the robotic assisted laparoscopic suprapubic simple prostatectomy while using the device to suction the surgical site, dark brown/grey liquid was leaking from the battery compartment.Device was removed from the field.No patient/staff harm from liquid.

• Brand Name: STRYKEFLOW SUCTION/IRRIGATOR
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): STRYKER; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 6545913
• MDR Text Key: 74495246
• Report Number: 6545913
• Device Sequence Number: 1
• Product Code: LJH
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 250-070-520
• Device Lot Number: 16328FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2017
• Event Location: Other
• Date Report to Manufacturer: 04/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR