MAUDE Adverse Event Report: ETHICON ETHICON; HARMONIC SCALPEL

Model Number HARHD36 1000ISHEARS

Device Problems Melted (1385); Device Displays Incorrect Message (2591)

Patient Problem Injury (2348)

Event Date 11/16/2017

Event Type  Injury  

Event Description

During laparoscopic hiatal hernia repair using harmonic scalpel, the scalpel malfunctioned.The machine alerted the surgical team, scalpel was withdrawn and examined, the plastic jaws of the grasper appeared to have been melted.Instrument removed from the field and a new one obtained.To evaluate the esophagus and stomach a gastroscope was used, while blanching of the anterior left lateral segment of the distal esophagus was noted (concern for cautery injury.) scope then passed to the stomach and a gastrotomy injury was identified as well.Scope with drawn, distal esophageal lesion reevaluated, bubbling seen from the laparoscopic view and a tear was identified.Converted to an open procedure and exploratory lap done with repair of esophageal tear and gastrotomy.

• Brand Name: ETHICON
• Type of Device: HARMONIC SCALPEL
• Manufacturer (Section D): ETHICON
• MDR Report Key: 7078795
• MDR Text Key: 93735868
• Report Number: MW5073695
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: HARHD36 1000ISHEARS
• Device Lot Number: P93KOU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 72