SALINE FILLED TESTICULAR PROSTHESIS

Description of Event or Problem

DATE OF EVENT: (B)(6)2009. ACCORDING TO THE AVAILABLE INFORMATION, THIS SALINE TESTICULAR DEVICE WAS TO BE IMPLANTED ON (B)(6)2009 BUT WAS NOT DUE TO DEVICE HAD A HOLE IN IT WHEN OPENED. ADDITIONAL INFORMATION RECEIVED FROM THE TERRITORY MANAGER WHO WAS PRESENT AT THE SURGERY, INDICATED UPON FILLING THE DEVICE, SALINE BEGAN TO SHOOT OUT THROUGH WHAT APPEARED TO BE A SMALL HOLE. SURGEON CLAIMS HE DID NOT PUNCTURE THE IMPLANT WITH THE NEEDLE AND TM DID NOT WITNESS HIM DO SO. SURGERY WAS NOT DELAYED AS TM HAD A SECOND DEVICE OF THE APPROPRIATE SIZE IN THE OPERATING ROOM.

Additional Manufacturer Narrative

ONE TESTICULAR DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION AND TESTING OF THE RETURNED COMPONENT REVEALED A SEPARATION BETWEEN THE MID LINE AND INJECTION PORT ON THE SHELL OF THE DEVICE. TESTING REVEALED THIS TO BE THE SITE OF LEAKAGE. MICROSCOPIC EXAMINATION REVEALED THE SURFACE OF THE SEPARATION TO HAVE A CENTRAL GROOVE INDICATING THAT AREA WAS IN CONTACT WITH A SMALL SHARP INSTRUMENT SUCH AS A NEEDLE. BECAUSE THIS COMPONENT WAS RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED INSTRUMENT DAMAGE ON THE TESTICULAR SHELL OCCURED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. AS THE DEVICE WAS NEVER IMPLANTED, QA CONCLUDED THAT INSTRUMENT DAMAGE MOST LIKELY OCCURRED DURING THE PREPPING PROCEDURE.