MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC HARMONIC FOCUS HAND PIECE BLADE HOLDER; INSTRUMENT, ULTRASONIC SURGICAL

Device Problems Defective Device (2588); Output Problem (3005); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  malfunction  

Event Description

Harmonic focus hand piece defective release pressure on blade kept flashing across screen while md was trying to use it.Generator turned off and hand piece re-activated and the same message flashed on the screen again.

• Brand Name: HARMONIC FOCUS HAND PIECE BLADE HOLDER
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 16852911
• MDR Text Key: 314375203
• Report Number: 16852911
• Device Sequence Number: 1
• Product Code: LFL
• 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: 04/19/2023,09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/02/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Female