FDA Adverse Event Malfunction Summary report: N

HARMONIC LAP 5MM SHEAR 36CM

MDR report key: 7317900 · Received March 6, 2018

Report

Report Number: 3005075853-2018-08383
Event Type: Malfunction
Date Received: March 6, 2018
Date of Event: January 1, 2018
Report Date: February 21, 2018
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: LFL
UDI-DI: 20705036014444
PMA / PMN Number: K120729
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

(B)(4). BATCH # P94015. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED WITH NO APPARENT DAMAGE. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND TESTED ON A GEN11. THE DEVICE WAS FUNCTIONAL AND WORKED AS INTENDED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. THE INSTRUMENT WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS, NO EVIDENCE WAS FOUND THAT COULD HAVE CAUSED THE REPORTED ACTIVATION ISSUES. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT OF THE DEVICE HAS FIRED INDEPENDENTLY. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NC¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

Additional Manufacturer Narrative · 1

(B)(4). DATE SENT: 3/6/2018. BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED INDEPENDENTLY. NO USER HAS FIRED THE DEVICE. NO HARM TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
158751	HARMONIC LAP 5MM SHEAR 36CM	INSTRUMENT, ULTRASONIC SURGICAL	LFL	ETHICON ENDO-SURGERY, LLC.			20705036014444

Patients

Seq	Age	Sex	Outcome	Treatment
1