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

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by surgical staff that a reprocessed harmonic device was not properly working.The device was removed from service and replaced with a working device.The procedure was completed as planned with no harm to the patient.The device was given to clinical engineering.Upon physical examination, there were no visible defects to the device.It will be returned to the reprocessing manufacturer for failure analysis.The stryker sustainability representative has been notified and we will return this device for failure analysis.

• Brand Name: N/A
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region ct; lakeland FL 33815
• MDR Report Key: 7185439
• Report Number: 7185439
• Device Sequence Number: 1863527
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2018
• Report Date (Section F): 01/02/2018

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
• Operator of Device: Physician
• Device Expiration Date: 10/17/2018
• Device Model Number: N/A
• Device Catalogue Number: HAR36
• Device Lot Number: 7296296
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 70
• Date Report Sent to FDA: 01/02/2018