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

Catalog Number HAR36

Device Problem Fluid/Blood Leak (1250)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 07/01/2014

Event Type  Injury  

Event Description

It was reported the doctor had performed a laparoscopic cholecystectomy with the harmonic instrument and the patient developed cystic duct bile leakage after the case was completed.The patient received endoscopic retrograde cholangiopancreatography with stents to resolve the bile leakage issue.The harmonic device was discarded.

Manufacturer Narrative

(b)(4).Device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent only month and year known, assumed 1st day of month (july 2014) that complaint was reported.Additional information from sales rep: surgeon explained the patient had an ercp and was stented.They were not brought back to the or.I asked him about his technique and he stated that he sets the minimum level to 2 on the generator and utilizes the minimum button.Normally, it takes a while to achieve the att elevated tone and he lets the tissue melt or transect off of the blade.He noticed a leak on the gall bladder side, but not the patient side.That patient has not presented with any problems postoperatively.

• 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 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4239796
• MDR Text Key: 4990031
• Report Number: 3005075853-2014-07758
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2014

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: HAR36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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