MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC.; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH45

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2015

Event Type  malfunction  

Event Description

During a bariatric case, the harmonic turned itself off and had to be reset.This happens very frequently now.The ethicon sales rep has been notified since we have been having issues with the device.He has advised us to pull the disposable handpiece and non- disposable cord.Both items were taken to purchasing and then released to the ethicon rep.Ethicon will be bringing a team of engineers to the hospital because of all the issues we have with the harmonic device.Manufacturer response for harmonic with handpiece, (brand not provided) (per site reporter).
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ethicon rep will be bringing a team of engineers to the hospital because of all the issues we have with the harmonic device.

• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 4717198
• MDR Text Key: 5737707
• Report Number: 4717198
• Device Sequence Number: 1
• Product Code: LFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/26/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: HARH45
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2015
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 142