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

Catalog Number HP054CN

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t92z80.Investigation summary.The hand piece was received with the cable insulation damaged.In addition the housing was not broken nor damaged as reported.However this did not create a functional issue.The device was connected to a generator, evaluated with a test instrument and was found to be functional.The instrument was disassembled to perform an internal electrical test that revealed a hand activation open circuit condition at the cable level, affecting the functionality of the handpiece.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.No conclusion could be reached as to what caused this issue.Possible causes that may have contributed to the cable damage include the cable being ran over, or getting tangled by the cart wheels.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the handle was broken.The inner core of the handle broke.Changed to another one to complete surgery.There was no patient consequence reported.

Manufacturer Narrative

(b)(4).

• Brand Name: HARMONIC SCALPEL HAND PIECE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10135669
• MDR Text Key: 194618678
• Report Number: 3005075853-2020-02926
• Device Sequence Number: 1
• Product Code: LFL
• 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
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HP054CN
• Device Lot Number: T92Z80021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Date Manufacturer Received: 05/18/2020
• Patient Sequence Number: 1
• Treatment: GENERATOR