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

Catalog Number HP054

Device Problems Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r94u5f.Investigation summary: the device was received with no apparent damage.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.The moisture indicator was positive.The handpiece has a number of seals to prevent fluids from entering the housing."positive moisture indicator¿ 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 manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.

Event Description

It was reported that during an unknown procedure, the harh45 did not work.They verified the hand piece and it still had uses available.When they change the energy device to another harh45, that one worked fine, but the first one gave an error on the gen11.No patient consequence.

• 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: 9626754
• MDR Text Key: 204400449
• Report Number: 3005075853-2020-00526
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• 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: 01/09/2020
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1