MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKERFLOW 2 SUCTION/IRRIGATOR; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 0250070520

Device Problems Degraded (1153); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

The suction/irrigator was opened to the sterile field and connected to the saline bag in usual fashion.After the surgeon started to irrigate, clear liquid was dripping out of the bottom of the battery pack.The paper seal on the bottom of the battery pack was not intact.The surgeon and scrub tech were immediately notified.The suction/irrigator was removed from the sterile field.A new suction/irrigator was opened to the sterile field and connected to the saline bag in usual fashion.It operated as expected.The surgeon proceeded without further incident.

• Brand Name: STRYKERFLOW 2 SUCTION/IRRIGATOR
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 16784740
• MDR Text Key: 313727093
• Report Number: 16784740
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0250070520
• Device Catalogue Number: 250-070-520
• Device Lot Number: 23058FG2
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Male