MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR36

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 12/13/2016.Batch # n91w1z.Additional information was requested and the following was obtained: was the active blade tip broken off during the procedure? i do not know.Upon packaging of the instrument to be shipped i noticed the tip was broken off.I looked in the red biohazard bag that i had received the product in and was unable to locate the tip.I went to the account and spoke to the circulator and the scrub nurse neither of whom expressed concerns that the tip had broken off in the patient.The scrub explained that he actually squeezes the tip of the instrument when assembling and disassembling rather than closing the jaws with the handle.That being said, he thought he would have noticed for sure if something was off.The doctor was not in the or so i emailed him the findings.Did the broken blade tip fall into the patient? not that i know of.The staff did not think it did.Was the broken blade tip retrieved from the patient? no, but they don't think it ended up in there.Did this cause a change in the plan of care for the patient? at this point in time no.The device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched, and with 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: "they had received the error message relax pressure on blade which they addressed then the generator said tighten assembly".During functional testing on gen11 an alert screen was displayed.A probable cause of the device stop activating and display an alert screen is blade damage.The device was disassembled to inspect the internal components and no anomalies were found.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 or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activations may increase damage severity and result in alert screens, such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.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 biliary pancreatic diversion surgery (bpds) procedure, the rep was called into the room over the intercom.Upon arrival the staff informed the rep they had received the error message relax pressure on blade which they addressed then the generator said tighten assembly which they did.They received that error message again so they decided to change the hp054 in case something was wrong with the handpiece.After changing that they continued to receive the same error messages so they decided to open a new disposable.A second hp054 and a second har36 was pulled to complete the procedure.There were no adverse consequences for the patient.

• Brand Name: HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY
• 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: 6171480
• MDR Text Key: 62616690
• Report Number: 3005075853-2016-06995
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120729
• 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: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Catalogue Number: HAR36
• Device Lot Number: N91W1Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2016
• 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 AND HANDPIECE