MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON; HARMONIC HD 1000I SHEARS

Catalog Number 01HARH036

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/19/2018

Event Type  malfunction  

Event Description

This is being reported as a patient safety concern.The new harmonic scalpel malfunctioned.The white, non-stock coating on the blade of the scalpel came loose from the device which made it dangerous to continue using on the patient.The harmonic was removed from the field.

• Brand Name: ETHICON
• Type of Device: HARMONIC HD 1000I SHEARS
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC. ; 4545 creek rd. ; cincinnati OH 45242 2839
• MDR Report Key: 7467788
• MDR Text Key: 106959455
• Report Number: MW5076810
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 01HARH036
• Device Lot Number: R92759
• Other Device ID Number: 5MM DIAMETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2018
• 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: 38 YR