CURVED DCR BUR 1882969

Report

Report Number: 1045254-2010-00036
Event Type: Malfunction
Date Received: August 5, 2010
Date of Event: July 8, 2010
Report Date: July 9, 2010
Manufacturer: MEDTRONIC XOMED, INC.
Product Code: EQJ
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THE FACILITY REPORTED 3 SEPARATE EVENTS TOGETHER. REFERENCE MEDWATCH REPORT NUMBERS, 1045254-2010-00034, AND 1045254-2010-00035. THE REPORT INDICATED THAT ALL THREE OCCURRENCES HAD TIP BREAKAGE AND WERE RETRIEVED FROM THE PATIENTS WITHIN THE SAME PROCEDURE. THE FACILITY STATED THAT THE DEVICE IN QUESTION WAS DISCARDED AND NO LOT NUMBER WAS IDENTIFIED; THEREFORE, A RESERVE SAMPLE COULD NOT BE IDENTIFIED AND A PRODUCT ANALYSIS COULD NOT BE PERFORMED. APPLICABLE SECTIONS OF THIS REPORT COULD NOT BE COMPLETED AS A RESULT. INSTRUCTIONS FOR USE STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: "EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE. SHOULD A BUR FRACTURE OCCUR DURING USE, EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BUR ARE RETRIEVED AND REMOVED FROM THE PATIENT. UNREMOVED BUR FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PATIENT." THE REPORTED PATIENT'S AGE WAS (B)(6). THE REPORTED DATE OF THE EVENT/ FACILITY AWARE DATE IS ON OR ABOUT (B)(6) 2010.

Description of Event or Problem · 1

DURING A DACRYOCYSTORHINOTOMY (DCR) PROCEDURE, THE BUR TIP BROKE AND THE SURGEON HAD TO RECOVER A PORTION OF THE BUR FROM THE SURGICAL FIELD. THE PATIENT IS OK WITH NO IMPACT TO REPORT. THE BUR TIP WAS REMOVED WITHOUT THE USE OF ADDITIONAL EQUIPMENT OR SURGICAL PROCEDURE AND THE ORIGINAL PROCEDURE PROCEEDED AS INTENDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CURVED DCR BUR 1882969	77EQJ	EQJ	MEDTRONIC XOMED, INC.	1882969	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR