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

Catalog Number HP054

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p93a1x.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 non-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 a laparoscopic appendectomy procedure, it was deactivating.Generator must be restarted for use, however, it did not work.Another device had to be used to proceed with the surgery.There was 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
• 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: 7704707
• MDR Text Key: 114717391
• Report Number: 3005075853-2018-11390
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036002144
• UDI-Public: 20705036002144
• 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: 07/05/2018

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: 06/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• 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