MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; SCALPEL, ULTRASONIC, REPROCESSED

Lot Number UNKNOWN

Device Problems Failure to Read Input Signal (1581); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 01/22/2018

Event Type  malfunction  

Event Description

Malfunction of a harmonic reprocessed device - the green button would not work.

• Brand Name: N/A
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region ct; lakeland FL 33815
• MDR Report Key: 7298704
• MDR Text Key: 101113858
• Report Number: 7298704
• Device Sequence Number: 1
• Product Code: NLQ
• 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: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2018
• 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: 62 YR