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

Catalog Number 250-070-620

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Information (3190)

Event Date 08/11/2017

Event Type  malfunction  

Event Description

The suction button on the device does not work.The device is constantly on suction and the physician is unable to control it.A new device was open.

• 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: 6954872
• MDR Text Key: 89512938
• Report Number: 6954872
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 250-070-620
• Device Lot Number: 17138FG2
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1