MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. HARMONIC FOCUS; SCALPEL, ULTRASONIC, REPROCESSED

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2020

Event Type  malfunction  

Event Description

From staff: the harmonic handpiece would not connect with the power source, and while doing the mandatory testing to start it up, the surgical tech felt an unusual clicking.We chose to replace it with a new one and everything worked correctly with the new handpiece.

• Brand Name: HARMONIC FOCUS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region court; lakeland FL 33815
• MDR Report Key: 10493593
• MDR Text Key: 205692013
• Report Number: 10493593
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: (01)07613327348248
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HAR9F
• Device Lot Number: 11619361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Weight: 66