MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE + 7; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH36

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent: 11/3/2016.No lot or batch number was provided therefore a device history could not be done.Additional information was requested and the following was obtained: were you present for the procedure? yes.How long has the surgeon been using the harmonic +7 device? first time.Long time harmonic focus user.Was the surgeon in-serviced prior to using the harmonic +7 device? yes.Did the gen11 display any yellow alert screens during the procedure? no.What technique was used with respect to the advanced hemostasis and the min/max button.Min button was the only button used.How were these features used in/around the esophageal? 3-4 activations were used on the diverticulum.How was it determined that the harh36 caused the esophageal leak/hole? unknown.What caused the hole? unknown.When was the leak noticed? the following day [the event lists the leak occurred and then the hole was repaired and then the patient being brought back to the or.Is this the correct order of events?] patient brought back to or to fix the leak.Hole noticed in esophageal tissue.

Event Description

It was reported that during a zenker's diverticulum procedure, the patient presented with esophageal leak posterior.Hole repaired with vicryl suture to complete the procedure.The patient was brought back to the or thirty-six hours after the initial procedure due to the esophageal leak.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: were there any other instruments used during the initial procedure other than harh36: suture; how did the patient present with the esophageal leak: later that night following the procedure; what was the location of the hole in reference to the surgical procedure: please refer to original compliant; was there thermal damage at the site of the hole in the re-operation: the suture stated yes; does the surgeon believe that the leak was created by using the harh36: yes.

• Brand Name: HARMONIC ACE + 7
• 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: 6075331
• MDR Text Key: 59033920
• Report Number: 3005075853-2016-06263
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARH36
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE