TOROSA
Received Aug 21, 2013
Report 3352294 · MDR key 3352294
Device
Generic name
Prosthesis, Testicular
Manufacturer
Coloplast CorporationModel number
*Catalog number
450-1329
Lot number
3660017
Product problems
- Leak/Splash
- Packaging Problem
Patient
*
- No Patient Involvement
Narrative
Description of Event or Problem
THE NIGHT PRIOR TO THE SURGERY THE PHYSICIAN REVIEWED THE YOU-TUBE VIDEO TO REFRESH HIS KNOWLEDGE ON USE AND FILLING OF THE PROSTHETIC IMPLANT. ON THE DAY OF SURGERY THE FIRST IMPLANT WAS FILLED AND WAS FOUND TO HAVE A LEAK. THE SECOND PROSTHESIS WAS FILLED AND WAS ALSO FOUND TO HAVE A LEAK. AS ONLY TWO IMPLANTS WERE AVAILABLE WITHIN THE LOCAL AREA, THE PATIENT WAS CLOSED WITHOUT THE IMPLANT. UPON REVIEW OF THE CASE IT WAS FOUND THAT WHILE THE YOU-TUBE VIDEO OPENS WITH A SCREEN DISCUSSING USE OF A NEEDLE STOP, THE VIDEO ITSELF DOES NOT SHOW THE NEEDLE STOP IN USE DURING ANY PART OF THE VIDEO. IT WAS ALSO DISCOVERED THAT THE NEEDLE STOPS ARE NOT IDENTIFIED INSIDE THE PACKAGING. THE MANUAL THAT COMES WITH THE PACKAGE MAKES A REFERENCE TO THE NEEDLE STOP ON PAGE 7 BUT DOES NOT HAVE ANY DETAILS ON WHAT IT LOOKS LIKE.