MAUDE Adverse Event Report: ETHICON ETHICON; LAPAROSCOPIC HARMONIC SHEARS

Model Number HAR36

Device Problems Break (1069); Device Issue (2379)

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

Event Date 04/26/2016

Event Type  malfunction  

Event Description

During use of laparoscopic harmonic handpiece, device began to malfunction.Upon removal of device for closer examination, one of the end prongs broke and detached from the device.The device was not in use inside patient at the time.

• Brand Name: ETHICON
• Type of Device: LAPAROSCOPIC HARMONIC SHEARS
• Manufacturer (Section D): ETHICON; cincinnati OH 45242
• MDR Report Key: 5729076
• MDR Text Key: 47668710
• Report Number: 5729076
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: HAR36
• Device Lot Number: M92Y88
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR