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

Model Number 0250070520

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

The suction irrigator was hooked up to a bag of saline as well as suction, which was off the sterile field.However, the tubing attached to these parts was on the sterile field.The battery pack (at the bottom of the tubing near the spiked bag of fluid) was leaking brown liquid.Charge nurse was notified, and product was taken out of the or.Reference #(b)(4); lot#21116f62; exp: 2023-04-26.

• 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: 12134172
• MDR Text Key: 260552153
• Report Number: 12134172
• 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: 07/02/2021

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: 21116F62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9490 DA