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

Catalog Number HARHD36

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch n93p3h.The device was returned with the tip of the blade broken off and not returned with the device.The remaining blade portion was scratched ¿ 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.The reported complaint was for activation issues.Dry body fluids were observed on the shaft and handle.The device was connected to the gen11/pi key to test functionality.It did not pass functionality testing.There were metal contact marks observed on the blade.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 records were reviewed and the manufacturing criteria were met prior to the release of the batch.

Event Description

It was reported that during a laparoscopic gastric bypass band revision procedure, was informed by the staff at facility that the device stopped working mid surgery.No additional details were given.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

• 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: 6308471
• MDR Text Key: 67114919
• Report Number: 3005075853-2017-00789
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2017

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 Expiration Date: 11/13/2021
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• 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
• Treatment: GENERATOR