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

Catalog Number HAR36

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r93d19.Investigation summary: the device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched and had evidence of contact with metal in or out of the operative field.This blade tip portion may have broken off of the device during transport to our analysis site.During functional testing on a gen11, an alert screen was displayed.A probable cause for the device to stop activating and for the gen11 to display an alert screen is blade damage.The device was disassembled to inspect the internal components and no anomalies were found related to the reported event.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, contact with staples or clips during the procedure or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activation may increase the severity of the blade damage.This, in turn, can result in the device failing the pre-run test with the generator and displaying an alert screen.The alert screens that can result may include ¿tighten assembly,¿ ¿blade error detected,¿ or "relax pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damaged blade can result in a broken blade.The batch history record was reviewed and there were no defects, protocols, or ncr(s) found during the manufacturing process related to this complaint.

Event Description

It was reported that during an unknown procedure, the device could not be activated.Changed to another device to complete the procedure.There was no report on patient injury.

Manufacturer Narrative

(b)(4).Additional information was received from the affiliate: "please get noted that the titanium blade tip was not left in the patient after confirmed with our sales, thanks.".

• 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
• MDR Report Key: 8220553
• MDR Text Key: 132514207
• Report Number: 3005075853-2019-15539
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014447
• UDI-Public: 10705036014447
• 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
• Type of Report: Initial,Followup
• Report Date: 12/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: HAR36
• Device Lot Number: R93D19
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2019
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE