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

Model Number N/A

Device Problems Loss of Power (1475); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  malfunction  

Event Description

The pt was undergoing a surgical procedure, when the surgeon was using the harmonic focus shears and adaptive tissue technology 9cm.The instrument stopped working in the middle of the procedure.It was removed from the sterile field and replaced so the surgeon could continue.No harm noted to the pt.Fda safety report id# (b)(4).

• Brand Name: HARMONIC FOCUS SHEARS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 9244404
• MDR Text Key: 164091782
• Report Number: MW5090661
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: (01)07613327348248
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: N/A
• Device Catalogue Number: HAR9F
• Device Lot Number: 10603499
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR