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

Catalog Number HARH36

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Bleeding (1738); Surgical procedure, repeated (2042); Transfusion of blood products (2337); Surgical procedure (2357); Blood Loss (2597)

Event Date 05/16/2015

Event Type  Injury  

Event Description

It was reported that during a gastro esophageal reflux and hernia repair laparoscopic procedure, it was the first time that the surgeon used the device.At the beginning of the procedures, the sales representative had transferred the hemostasis from advanced to minimum.The surgeon reported that the device was slow to coagulate and asked her to return it to the normal settings.There were no intraoperative complications and the generator and the device worked without any problem.The surgeon didn¿t report more problems with the device.After these procedures, the sales rep talked with surgeon and he reported that he would have to re-operate the patient by laparoscopy because he had forgotten a "fat" in the patient.The sales rep wasn¿t present in this procedure.At about 9:30 p.M.The sales rep was informed by the doctor¿s instrumentation technician that the patient was re-operated once she had lost a lot of blood and her blood pressure was very low (hypovolemia).The blood was coming out through the drain.The patient was opened by laparotomy and the surgeon found that a vessel that had been sealed with the device was opened.They reported that bleeding occurred in a vase located in the stomach region in which the ligature procedure was made.The patient was submitted to blood transfusion and now she in the uti.Unknown how case was completed.

Manufacturer Narrative

(b)(4).Information not available, device not returned for analysis should the information be provided later, a supplemental medwatch will be sent additional information: surgeon advised that the first surgery was very smooth, with almost no bleeding during the procedure, and that approximately 3 hours after the end of it the patient's blood pressure started to fall and the patient had a hypovolemic shock.He the performed another surgery (this time an open one) and discovered a short vessel that he supposedly had sealed with harh36 in the first procedure bleeding.His opinion is that when the patient recovers from the anesthesia of the first surgery her bp was raised and the vessel started bleeding.He thinks this was causes by a malfunction of harh36, which had already been disposed of.He said nothing about forgetting any fat or performing a second surgery before the open one.Please explain statement about ¿the sales representative had transferred the hemostasis from advanced to minimum.¿ did the sales rep use the biomed settings to change the min to be the advanced hemo mode? the physician turned to the non-advanced mode because there were no large vessels and the advanced mode was not necessary.Regarding the device being slow to coagulate ¿ what is meant by slow? such as seconds slow? in fact the device was not slow, the rep said that in the advanced mode it is a bit slower and since there were no large vessels the physician turned to the non-advanced mode, where it is faster.

Manufacturer Narrative

(b)(4).Please explain statement about ¿the sales representative had transferred the hemostasis from advanced to minimum¿.Did the sales rep use the biomed settings to change the min to be the advanced hemo mode? the physician turned to the non-advanced mode because there were no large vessels and the advanced mode was not necessary.Regarding the device being slow to coagulate ¿ what is meant by slow? such as seconds slow? in fact the device was not slow, the rep said that in the advanced mode it is a bit slower and since there were no large vessels the physician turned to the non-advanced mode, where it is faster.

• Brand Name: HARMONIC ACE + 7
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 4820926
• MDR Text Key: 5901404
• Report Number: 3005075853-2015-03333
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

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?: 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
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention