FDA Adverse Event Injury Summary report: N

THERMACHOICE

MDR report key: 1790024 · Received August 2, 2010

Report

Report Number: 2210968-2010-00899
Event Type: Injury
Date Received: August 2, 2010
Date of Event: June 14, 2010
Report Date: July 6, 2010
Manufacturer: ETHICON, INC.
Product Code: MKN
PMA / PMN Number: P970021
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): CONCLUSION: TWO DEVICES WERE RETURNED FOR EVALUATION. IT IS UNKNOWN WHICH DEVICE IS RELATED TO THE EVENT. CATHETER (B)(4) WAS EVALUATED AND THE DEVICE WAS FOUND TO BE FUNCTIONAL FOR ELECTRICAL TESTING. CATHETER (B)(4) PASSED THE LEAK TEST. THE RESISTANCE WIRE AND HEATER CORE WERE FOUND TO BE DISCOLORED AND THE HOUSING IMPELLER WAS FOUND MELTED DUE TO HEAT. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE POSSIBLE BATCH NUMBERS: (B)(4), BATCH CBMG14 MFG DATE: 03/01/2010, EXP DATE: 03/31/2012. (B)(4), BATCH # CBMG03, MFG DATE: 03/01/2010, EXP DATE: 03/31/2012. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-00906. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6)2010. DURING THE PROCEDURE, AN ERROR MESSAGE OCCURRED DURING PRE-HEATING (BETWEEN 70-73 DEGREES CELSIUS). A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE PHYSICIAN SAW A MINOR BURN AT THE LEFT VAGINAL WALL (4 O'CLOCK). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	THERMACHOICE	CATHETER, BALLOON, TRANSCERVICAL	MKN	ETHICON, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Required Intervention