FDA Adverse Event Malfunction Summary report: N

ULTRACISION HARMONIC ACE

MDR report key: 3082803 · Received April 29, 2013

Report

Report Number: 3005075853-2013-02019
Event Type: Malfunction
Date Received: April 29, 2013
Date of Event: March 27, 2013
Report Date: April 26, 2013
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: LFL
PMA / PMN Number: K042777
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

Additional Manufacturer Narrative · 1

(B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED. WE DID NOT RECEIVE A VALID BATCH NUMBER OR LOT NUMBER SO THEREFORE WE WERE UNABLE TO REVIEW THE MANUFACTURING RECORDS

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A HIATOPLASTY/ GASTROPLASTY OF THE ESOPHAGUS SURGERY AT THE END OF THE PROCESS, ONE PART OF THE JAW BROKE PREVENTING THE USE OF DEVICE. THE PIECE WAS FOUND IN THE O.R. - NOTHING FELL INTO THE PATIENT. NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
185001	ULTRACISION HARMONIC ACE	INSTRUMENT, ULTRASONIC SURGICAL	LFL	ETHICON ENDO-SURGERY, LLC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR			GENERATOR AND HANDPIECE