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

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 01/07/2016

Event Type  malfunction  

Event Description

During the laparoscopic right nephrectomy, a sealer of the harmonic jaw was slipped out in the patient peritoneal cavity.Dr.Took out the whole piece of sealer.

• Brand Name: HARMONIC
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY INC.; 4545 creek road; cincinnati, OH 45242
• MDR Report Key: 5356710
• MDR Text Key: 35513046
• Report Number: 5356710
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Other Device ID Number: HARMONIC SCALPEL 5MM X 36CM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR