MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC HARMONIC ACE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARH36

Device Problems No Device Output (1435); Failure to Cut (2587)

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

Event Date 07/19/2021

Event Type  malfunction  

Event Description

Multiple events in the last several months similar to the reported event on a previous medsun report.The device involved in all these events is the ethicon endo-surgery, llc harmonic ace +7 laparoscopic shears advanced hemostasis 5mm diameter 36cm shaft length for use with gray hand piece only.Event occurrence date: notes: lot #: (b)(6) 2021 stopped working u95206, (b)(6) 2021 stopped working u95m66, (b)(6) 2021 stopped working u95m66, (b)(6) 2021 stopped working v95m66, (b)(6) 2021 stopped working v94d6a, (b)(6) 2021 the harmonic shears malfunctioned during use and needed to be replaced mid-case.U9391c , v9414h , u9391c , (b)(6) 2021 harmonic harh36 stopped working u95206, (b)(6) 2021 harmonic stopped working, replaced with new harh36 u9540k,  (b)(6) 2021 harmonic scalpel harh36 not working correctly and did not cut through tissue u95r4l.

• Brand Name: HARMONIC ACE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 12252078
• MDR Text Key: 264312491
• Report Number: 12252078
• 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: 07/22/2021

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
• Device Operator: Health Professional
• Device Model Number: HARH36
• Device Catalogue Number: HARH36
• Device Lot Number: U9540K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 61