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

Catalog Number HP054

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p93w1f.Investigation summary: the device was received with no apparent damage.It was evaluated with a test instrument and a ¿no uses remaining- replace handpiece¿ alert screen was displayed by the generator when it was connected to perform the functional testing.Further analysis confirmed that the handpiece had already been used 95 times.The handpiece is a re-useable instrument with a limited service life.The device is programmed with a counter to limit the service life to 95 procedures.The ¿no uses remaining- replace handpiece¿ alert screen advises that the handpiece has reached the end of life.This is not related to a functional failure.The instrument was disassembled to inspect the internal components and there was moisture present.The handpiece has a number of seals to prevent fluids from entering the housing.¿moisture present¿ describes a condition where water enters the handpiece cavity during the steam sterilization process.The primary path of ingress is the distal seal.This may be caused by a reduction of the compressive force on the distal seal.However, no definitive root cause could be drawn.It is probable that the ingress of moisture affected handpiece functionality.The ¿replace handpiece¿ alert screen advises that the hand piece has failed to perform the internal diagnostic routines and the generator will not be able to operate the hand piece reliably.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the device did not function, possibly due to end of number of uses.There was no harm on patient and no delay to procedure.Used another one to proceed.

• Brand Name: HARMONIC SCALPEL HAND PIECE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8941582
• MDR Text Key: 202203981
• Report Number: 3005075853-2019-21591
• 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: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• 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: 08/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1