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 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #n91g9z.Investigation summary: the hand piece was received with the nose cone cracked.In addition, coating material of the housing was flaking off.Based on prior investigations, the loose particles on the surface are likely aluminum oxide from the base material.It was evaluated with a test instrument and a ¿no uses remaining- replace hand piece¿ alert screen was displayed by the generator when it was connected to perform the functional testing.Further analysis confirmed that the hand piece has already been used 95 times.The instrument was disassembled to inspect the internal components and the moisture indicator was positive.Due to the cracked nose cone, moisture entered the hand piece mid housing.The hand piece is a reusable 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 hand piece¿ alert screen advises that the hand piece has reached the end of life.This is not related to a functional failure.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.Analysis was unable to determine the exact root cause that lead to crack in the hand piece nose cone.It is possible that the ingress of moisture affected hand piece functionality.

Event Description

It was reported that the device does not function properly.No patient consequences were reported.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9513042
• MDR Text Key: 191855070
• Report Number: 3005075853-2019-24730
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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: 12/09/2019
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1