MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC HARMONIC ACE +7 LAPAROSCOPIC SHEARS; INSTRUMENT, ULTRASONIC SURGICAL

Model Number REF: HARH36

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 02/05/2021

Event Type  malfunction  

Event Description

The rubber pad on the harmonic shears tip came off on one side making it metal to metal contact.Md found rubber pad that came loose.No harm to the patient and all pieces were accounted for.Fda safety report id # (b)(4).

• Brand Name: HARMONIC ACE +7 LAPAROSCOPIC SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 11337632
• MDR Text Key: 232825145
• Report Number: MW5099427
• Device Sequence Number: 1
• Product Code: LFL
• 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: 02/12/2021

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: REF: HARH36
• Device Lot Number: U95616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2021
• 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: 38 YR
• Patient Weight: 142