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

Model Number HAR36

Device Problems Defective Component (2292); Component Missing (2306); Contamination /Decontamination Problem (2895); Temperature Problem (3022)

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

Event Date 08/24/2022

Event Type  malfunction  

Event Description

The harmonic scalpel was not working properly then we noticed that a piece was falling off.The blade was missing a serrated white piece on upper movable piece.Noted some white residue on forcep in location of missing piece.The shaft became very hot.We stopped using and used a ligasure instead and successfully completed the procedure with no patient impact.The generator, cord and disposable piece were all brought out to the surgical desk and were delivered to our biomedical engineering department for inspection.Biomedical reported that the generator was tested and was within spec.The device is available for inspection and is available to be returned to the manufacturer upon their request to ship it to them.

• 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: 15462259
• MDR Text Key: 300386514
• Report Number: 15462259
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014447
• UDI-Public: 10705036014447
• 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: 09/12/2022,09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• 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: 09/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Sex: Female