FDA Adverse Event Malfunction Summary report: N

ULTRACISION HARMONIC SCALPEL HAND PIECE

MDR report key: 4182457 · Received October 17, 2014

Report

Report Number: 3005075853-2014-07211
Event Type: Malfunction
Date Received: October 17, 2014
Date of Event: September 11, 2014
Report Date: September 11, 2014
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: LFL
PMA / PMN Number: K002906
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(6). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. CRACKED NOSE. THE HANDPIECE WAS RECEIVED WITH THE NOSE CONE CRACKED AND THE MOUNT WAS NOTED TO BE LOOSE. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE NOSE CONE WAS EXTREMELY CRACKED AND NO INSTRUMENT COULD BE ATTACHED TO THE HANDPIECE. THE INSTRUMENT WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. THE MOISTURE INDICATOR WAS POSITIVE, THE ACOUSTIC ISOLATOR WAS TORN. THE TRANSDUCER ASSEMBLY WAS NOT HELD IN PLACE DUE TO THE CRACKED NOSE CONE, SO TORQUING ON THE DISPOSABLE RESULTED IN TWISTING ONLY THE HANDPIECE TRANSDUCER ASSEMBLY UNTIL THE INTERNAL WIRES GOT DISCONNECTED. DUE TO THE CRACKED NOSE CONE, MOISTURE ENTERED THE HAND PIECE MID HOUSING. A POSSIBLE CAUSE OF THE NOSE CONE BEING CRACKED IS THE STERILIZATION METHOD DUE TO THE HEATING AND COOLING OF THE STERILIZATION CYCLES IS A STRESSOR.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER COULD NOT ATTACH THE HARH45 TO THE HAND PIECE. CUSTOMER TRIED TWO OTHER HARH45 AND HAD THE SAME ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
660802	ULTRACISION HARMONIC SCALPEL HAND PIECE	INSTRUMENT, ULTRASONIC SURGICAL	LFL	ETHICON ENDO-SURGERY, LLC.	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				GENERATOR AND DISPOSABLE