MAUDE Adverse Event Report: STRYKER ENDOSCOPY; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7208000000

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2017

Event Type  malfunction  

Event Description

Stryker system saw 7 became very hot while the surgeon was using the device.A photo of the device with identifying numbers will be e-mailed.Event states no patient involved.No clinical outcome or consequences.Rep from stryker is aware of the issue and is sending a loaner.A new device was brought to the room and used to complete the case.

• Brand Name: NA
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 6416849
• MDR Text Key: 70338400
• Report Number: 6416849
• Device Sequence Number: 1
• Product Code: DWI
• 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: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 7208000000
• Device Catalogue Number: 7208000000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 86