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

Model Number 0250070520

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 06/04/2021

Event Type  malfunction  

Event Description

A stryker strykeflow disposable suction/irrigator started leaking at the juncture of the tubing and the battery pack.Doctor just wanted it to stop leaking until he could use it later on in the case.Nurse explained to the doctor that there was the potential that the fluid might be contaminated going into the patient.Doctor then opted to discard the device and get a new device.At the end of the case when cleaning up, nurse picked up the tubing and battery pack from the faulty/malfunctional device.The tubing fell out of the juncture where it should have been attached.The other suction irrigator given to the doctor to finish the case also had the same lot number 21032fg2 as the faulty/malfunctional device.

• 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: 12065886
• MDR Text Key: 258411470
• Report Number: 12065886
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 21032FG2
• 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: 06/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Weight: 92