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); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p91c3u.Investigation summary: the device was returned along with three photo images.Image 1 is that of the distal end of an hd1000i harmonic device.In the image, the clamp arm appears to be hyperextended.The image shows that the clamp arm has become dislodged from the outer tube.The clamp arm also appears to be firmly attached to the inner tube.Image 2 is that of the distal end of an hd1000i harmonic device and image 3 is of the clamp arm interface of an hd1000i instrument.From these two images, no issue can be seen with the instrument.The actual device was returned with the clamp arm detached from the inner tube and not returned.The device was connected and tested on a gen11, the generator immediately displayed the "replace instrument" alert screen and the device could not be activated for further functional testing.Due to the device returned condition not all functional testing could be performed with the generator.Further testing identified that the eeprom was not programmed.The device was disassembled to inspect the internal components and no anomalies were found associated with the issue.Possible causes of the clamp arm detachment are not closing the clamp when sliding the torque wrench on and off; not closing the clamp when introducing or removing through the trocar; or possible entanglement in fibrous tissue.The batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a laparoscopic hartman procedure, while using the harmonic had to keep cleaning the tips as it wouldn't work.Then the one tip seemed to be a bit loose.When trying to remove the harmonic thru the 5mm trocar, physician was unable to remove it and had to remove the trocar and the harmonic.They were unable to pull out the harmonic from the trocar.Opened a second harmonic and it stopped working.The monitor displayed replace instrument.No patient consequence.

• 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: 7345881
• MDR Text Key: 102761829
• Report Number: 3005075853-2018-08576
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

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: P94E2D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/16/2018
• 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