MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKERFLOW 2; DISPOSABLE SUCTION/IRRIGATOR, SYSTEM, UROLOGICAL

Catalog Number 250-070-520

Device Problems Vibration (1674); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2018

Event Type  malfunction  

Event Description

Stryker flow 2 disposable suction irrigator with disposable tip was found on shelf with vibrating sound from within sealed box.Rn opened box to shut off and the only way to shut it off was to unscrew the battery pack.In doing so, the batteries were found to be extremely hot.Device was not used on pt.

• Brand Name: STRYKERFLOW 2
• Type of Device: DISPOSABLE SUCTION/IRRIGATOR, SYSTEM, UROLOGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY; san jose CA 95138
• MDR Report Key: 8071024
• MDR Text Key: 127418891
• Report Number: MW5081261
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2024
• Device Catalogue Number: 250-070-520
• Device Lot Number: 18115FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1