FDA Adverse Event Other Summary report: N

TALON ELECTROSURGICAL DEVICE, 15CM

MDR report key: 1215656 · Received October 20, 2008

Report

Report Number: 1056436-2006-00077
Event Type: Other
Date Received: October 20, 2008
Date of Event: March 15, 2006
Report Date: October 15, 2008
Manufacturer: ANGIODYNAMICS, INC.
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT WAS CONFIRMED. THE DEVICE WOULD NOT RETRACT OR DEPLOY. THIS WAS DUE TO CRUSHED SIDE WINDOWS. EVIDENCE CLEARLY SHOWS THAT THE TIP HAD IMPACTED ANOTHER HARD OBJECT. THE FLATNESS OF THE TIP SUGGESTS THAT THE DEVICE WAS EITHER DROPPED OR HAD COLLIDED WITH ANOTHER SOLID OBJECT OUTSIDE OF THE PT. NEITHER BONE NOR HARD TISSUE WOULD CAUSE THE TIP TO BE FLAT. ALSO, IT WOULD TAKE THIS TYPE OF FORCE TO CAUSE THE TROCAR WINDOWS TO COMPRESS. ALTHOUGH, THE DESCRIPTION STATES THAT ONE ABLATION WAS COMPLETED, THERE IS NO EVIDENCE OF ABLATED TISSUE ON OR WITHIN THE DEVICE. IT IS UNCLEAR EXACTLY WHEN OR HOW THE DAMAGE OCCURRED. THE DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY MANUFACTURING VARIANCES RELATED TO THIS EVENT.

Description of Event or Problem · 1

DR. WAS PERFORMING A HCC THERMO ABLATION OF 2.5 CM X 4 CM WITH A TALON NEEDLE. THE PROCEDURE SHOULD HAVE BEEN PERFORMED WITH 2 THERMO ABLATIONS BUT, AT THE END OF THE FIRST ONE, IT WAS NOT POSSIBLE TO PULL OUT THE HOOKS. IT WAS NECESSARY TO REMOVE THE DEVICE FROM THE PT AND OPEN A NEW NEEDLE TO FINISH THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TALON ELECTROSURGICAL DEVICE, 15CM	ELECTROSURGICAL DEVICE	GEI	ANGIODYNAMICS, INC.	NA	25216

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other