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

Catalog Number HARHD36

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned with the blade damaged with the tip off.The blade tip was not found in the package.This blade tip portion may have broken off the device during transport to our analysis site.Dry body fluids were observed on the shaft.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.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 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 a laparoscopic paraesophageal hernia procedure, the device displayed error code "clean device" came on, removed device and wiped it down.Followed steps to start again and same error code occurred.Cleaned device as well as shut down gen11 and reboot.Then gen11 asked to replace device.Procedure completed with same/like device.There was no adverse consequence to the patient reported.

• Brand Name: HARMONIC HD 1000I SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6844998
• MDR Text Key: 85637103
• Report Number: 3005075853-2017-04264
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160752
• 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: 07/21/2017

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1