FDA Adverse Event Other Summary report: N

STARBURST SEMI-FLEX, 25CM

MDR report key: 1215655 · Received October 20, 2008

Report

Report Number: 1056436-2006-00076
Event Type: Other
Date Received: October 20, 2008
Date of Event: April 24, 2006
Report Date: October 15, 2008
Manufacturer: ANGIODYNAMICS, INC.
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED FOR EVALUATION. THE PEEK TUBING AT THE JUNCTION HAD A CRACK. THE COMPLAINT WAS CONFIRMED. THE TROCAR WAS CRACKED AT THE JOINT. OVERHEATING OF THE DEVICE WAS DUE TO AN ELECTRICAL SHORT. THE EXACT CAUSE AND LOCATION OF THE SHORT COULD NOT BE DETERMINED. ELECTRICAL SHORT TESTING HAS RECENTLY BEEN IMPLEMENTED IN MANUFACTURING. THE DEVICE HISTORY RECORD REVIEW REVEALED NO MANUFACTURING VARIANCES AND NO TRENDS FOR THIS PARTICULAR FAILURE HAVE BEEN IDENTIFIED. CONTINUED MONITORING OF COMPLAINTS OF THIS TYPE WILL BE PERFORMED.

Description of Event or Problem · 1

TYPE OF RFA CASE: LUNG. AT THE TRANSITION FROM THE RIGID TO THE FLEXIBLE PART OF THE CANNULA SALINE SOLUTION DROPPED OUT AND THE CANNULA BECAME SO HOT THAT IT WAS IMPOSSIBLE FOR THE PHYSICIAN TO HOLD IT IN HIS HAND. THE CANNULA SMELLED LIKE BURNED PLASTIC AND SMOKE COULD BE SEEN. THE PHYSICIAN HAD TO STOP THE PROCEDURE AND CHANGE TO A NEW PROBE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STARBURST SEMI-FLEX, 25CM	RF PROBE	GEI	ANGIODYNAMICS, INC.	NA	25815

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other