MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE PLUS 7 W ADV HEMOSTASIS; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH36

Device Problems Break (1069); Fracture (1260); Failure to Cut (2587)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that a harmonic disposable device was used during a total vaginal hysterectomy and bilateral salpingectomy related to abnormal uterine bleeding and dysmenorrhea.During the colpotomy portion of the procedure, the harmonic device appeared to have difficulty cutting and the machine noted increased pressure.With pressure released, the harmonic device appeared to function normally.At completion of the colpotomy, when the harmonic device was removed, the distal tip (approximately 2 mm) was noted to be broken.They physician clarified that a piece of the black active blade is what fractured and broke off.The physician noted that during the posterior aspect of the culpotomy, the harmonic device appeared to be 'fighting' him and the physician also noted they received a 'blade pressure' warning a couple of times on the generator screen.The piece could not be located despite an extensive search including immediate area, abdominal cavity, strain of suction canister contents, and inspection of specimens obtained.An abdominal x-ray did not find evidence of the broken piece in the patient¿s abdominal cavity and pelvis.A metal rumi uterine manipulator (from another manufacturer) was used for the procedure.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # r94643.Investigation summary: the analysis results found that the device was received with the tissue pad detached and not returned; with the blade tip intact and not broken off as reported by the customer.The device was connected to a test handpiece and tested on a gen11.The device was functional and worked as intended.There were no anomalies noted with the functionality of the device.The device was disassembled to inspect the internal components and no anomalies were found.It is possible that the device returned may have been the one used to complete the procedure and it is not the device complained about.Based on the condition of the tissue pad, a probable cause of this damage is that the clamp of the device may have been closed and the instrument activated without tissue present.Care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.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 resulting damage contributes to the removal of the pad from the clamp arm.The cleaning of the pad, not in accordance with the ifu, can also result in removal of the pad during use.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Manufacturer Narrative

(b)(4).Batch # r94k09.Additional information received: the following additional information was requested: did the patient have a re-operation? and if so, what was the reason for the re-operation? the following additional information was obtained: the rep believed the patient did return for a re-operation but the customer response was as follows: "i don¿t believe i mentioned whether the patient had a return to the or.Our review revealed that the additional treatment required was likely not device-related." attempts are being made to obtain clarification of the additional information received above from the customer and the following information was requested: what specifically was the additional treatment that the patient received? and what was the reason for the additional treatment? why do they believe treatment required was not likely device-related? to date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.Is adverse event: yes.Is required intervention: yes.Type of reportable event: serious injury.Patient code is no code available (surgical procedure).Result codes: cutter; fracture problem.Conclusion codes: unintended use error caused or contributed to event; failure to follow instructions.See corrected investigation summary below: investigation summary: the device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched and had evidence of contact with metal in or out of the operative field.In addition, a clip was returned inside a plastic bag.During functional testing on a gen11, an alert screen was displayed.A probable cause for the device to stop activating for and the gen11 to 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, contact with 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 activation may increase the severity of the blade damage.This, in turn, can result in the device failing the pre-run test with the generator and displaying an alert screen.The alert screens that can result may include ¿tighten assembly,¿ ¿blade error detected,¿ or "relax pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damaged blade can result in a broken blade.A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 1/28/2019.Corrected data= device manufacture date.Expiration date is 8/30/2023.Serial number is (b)(4).Device manufacture date is 9/28/2018.

• Brand Name: HARMONIC ACE PLUS 7 W ADV HEMOSTASIS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8229460
• MDR Text Key: 133147184
• Report Number: 3005075853-2019-15604
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014621
• UDI-Public: 10705036014621
• Combination Product (y/n): N
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Catalogue Number: HARH36
• Device Lot Number: R94K09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 12/12/2018; 01/25/2019; 01/31/2019
• Supplement Dates FDA Received: 01/24/2019; 01/28/2019; 02/20/2019
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR