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

Catalog Number HAR36

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

When harmonic ace shears were being used during laprascopic signoid colectomy, the machine instructed to relax pressure on handles and made the harmonic unable to be used.New harmonic opened.No harm to patient.

• Brand Name: HARMONIC ACE+
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road; cincinnati, OH 45242
• MDR Report Key: 4516015
• MDR Text Key: 18638305
• Report Number: 4516015
• 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: Invalid Data
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: HAR36
• Device Lot Number: L91U7Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR