MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC LAP 5MM SHEAR 36CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR36

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p93a23.Investigation summary: the device was returned with the blade tip broken off and returned.During functional testing on gen11 an alert screen was displayed.A probable cause for the device to stop activating and the gen11 to display an alert screen is blade damage.The device will stop activating when the blade becomes damaged.The device was disassembled to inspect the blade and the blade breaking point was located at an area inside the tube proximal to the tissue pad.Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn can result in failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.No conclusion could be reached as to what cause the damage blade.The damaged blade found is not related to the tissue effect issues reported.Due to the returned condition of the device we are unable to investigate further the reported issue.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the coagulation and cutting function was not good as usual.No patient consequence reported.

• Brand Name: HARMONIC LAP 5MM SHEAR 36CM
• 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: 8229051
• MDR Text Key: 132565673
• Report Number: 3005075853-2019-15600
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036014444
• UDI-Public: 20705036014444
• Combination Product (y/n): N
• PMA/PMN Number: K120729
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: HAR36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1