FDA Adverse Event Malfunction Summary report: N

ENDOCARE CRYOCARE CRYOPROBE, 1.7MM

MDR report key: 2870889 · Received December 12, 2012

Report

Report Number: 3008262715-2012-00035
Event Type: Malfunction
Date Received: December 12, 2012
Date of Event: November 16, 2012
Report Date: May 13, 2013
Manufacturer: HEALTHTRONICS, INC.
Product Code: GEH
PMA / PMN Number: K011074
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INVESTIGATION: PROBE SENT TO AN OUTSIDE WELDING EXPERT AND 3RD PARTY LAB TO CONDUCT A DETAILED INVESTIGATION. BASED ON THIS IT WAS DETERMINED THAT DURING THE PRE-SURGICAL PRESSURIZATION, THE WELD JUNCTION DEVELOPED A WELD CRACK. THE CRACK IN THE LASER WELD WAS DUE TO INSUFFICIENT WELD PENETRATION CAUSED BY POOR FIT-UP BETWEEN THE TROCAR TIP AND THE SHAFT. THE WELDING PROCESS WAS VALIDATED JOINTLY BY THE WELD VENDOR AND HEALTHTRONICS. THE SHAFT/TIP WELD IS VERIFIED 3 TIMES PRIOR TO PATIENT USE AND IN THIS INSTANCE THE LEAK WAS CAUGHT IN ONE OF THOSE VERIFICATIONS. (B)(4). THE WELD VENDOR HAS BEEN NOTIFIED THROUGH A SUPPLIER CORRECTIVE ACTION REPORT.

Additional Manufacturer Narrative · 1

DEVICE RECEIVED AND INVESTIGATION HAS BEEN STARTED. REPORTED FAILURE HAS BEEN CONFIRMED, HOWEVER INVESTIGATION IS ONGOING. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS KNOWN.

Description of Event or Problem · 1

BAD PROBE, FAILED PRETEST. ADDITIONAL INFORMATION RECEIVED (B)(6) 2012 - GAS LEAK FROM PROBE TIP DURING PRETEST. PROBE WAS NOT USED. OPENED ANOTHER PROBE, PRETESTED OKAY. CASE COMPLETED AS INTENDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOCARE CRYOCARE CRYOPROBE, 1.7MM	UNIT, CRYOSURGICAL, ACCESSORIES	GEH	HEALTHTRONICS, INC.	PERC-17	10655

Patients

Seq	Age	Sex	Outcome	Treatment
1