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 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r93j0j.Investigation summary: the handpiece was received with the nose cone cracked.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.Due to the cracked nose cone, moisture entered the hand piece mid housing.Analysis was unable to determine the exact root cause that lead to crack in the hand piece nosecone.It is possible that the ingress of moisture affected handpiece functionality.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that the device was not working.No patient consequence.No further information available.

• 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: 9010146
• MDR Text Key: 199104772
• Report Number: 3005075853-2019-21938
• 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
• Type of Report: Initial
• Report Date: 08/26/2019

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 Catalogue Number: HP054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• 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