MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARHD36

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch number n92e9e.Investigation summary
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> the device was returned with the blade damaged with the tip off.The blade tip was not found in the package.The blade tip portion may have broken off the device during transport to our analysis site.The tissue pad was damaged, melted, and 100% present.The device was connected to the gen11/pi key to test functionality.It did not pass functionality testing and the "replace instrument" alert screen was displayed.Metal marks were observed on the blades surface.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples or clips during the procedure.Once minor blade damage has occurred, subsequent activations may increase damage severity and result in alert screens, such as ¿blade error detected¿ or ¿relax pressure on blade¿ or ¿remove instrument from patient¿ followed by a ¿replace instrument¿ screen displayed on the generator.The probable cause of tissue pad damage is applying pressure between the instrument blade and tissue pad while activating the device without having tissue between the jaws.Prolonged usage of advanced hemostasis mode may cause tissue pad damage.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.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 the tissue pad separated in the middle and was loose at front after 15 minutes.No further information is available.

• Brand Name: HARMONIC HD 1000I SHEARS 36CM SHAFT
• 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: 7082291
• MDR Text Key: 95007065
• Report Number: 3005075853-2017-06438
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036015052
• UDI-Public: 20705036015052
• Combination Product (y/n): N
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2017

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: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1