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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2017

Event Type  malfunction  

Event 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
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region ct; lakeland FL 33815
• MDR Report Key: 7185439
• MDR Text Key: 97115152
• Report Number: 7185439
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347
• 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: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 70