MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HP054

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #unk.Investigation summary: the device was received with the coating material of the housing flaking off.Based on prior investigations, the loose particles on the surface are likely aluminum oxide from the base material.It was connected to a generator, evaluated with a test instrument, and was found to be functional.The instrument was disassembled to inspect the internal components and the moisture indicator was positive.Analysis was unable to determine the exact root cause that lead to crack in the hand piece nose cone.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.It is possible that the ingress of moisture affected hand piece functionality.Additional information was requested and the following was received: did the patient experience any adverse consequences due to this issue? no patient consequences.

Event Description

It was reported that during an unknown procedure, the generator displayed an error message saying it didn't detect the device after it was plugged in.There were no patient consequences.No additional information is available at this time.

• Brand Name: HARMONIC SCALPEL HAND PIECE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9924213
• MDR Text Key: 200037539
• Report Number: 3005075853-2020-02002
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036002147
• UDI-Public: 10705036002147
• Combination Product (y/n): N
• PMA/PMN Number: K002906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HP054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1