PROSTATE STABILIZATION SET 18GA X 20CM

Additional Manufacturer Narrative

WE CONDUCTED A THOROUGH REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT AND FOUND NO DEVIATIONS OR NON-CONFORMANCES. NO SAMPLES WERE RETURNED BY THE CUSTOMER FOR EVALUATION. ADDITIONALLY, THE PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CUSTOMER APPEARED TO SUPPORT THE REPORTED ALLEGATION. THE INABILITY TO RETRACT THE BARB MAY HAVE RESULTED FROM SEVERAL POTENTIAL FACTORS, INCLUDING TISSUE ENTRAPMENT OR MECHANICAL RESISTANCE. HOWEVER, WITHOUT RECEIVING THE SAMPLE, WE ARE UNABLE TO PERFORM A COMPREHENSIVE INVESTIGATION TO DETERMINE THE ROOT CAUSE. AS A RESULT, WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE OR ESTABLISH AN APPROPRIATE CORRECTIVE ACTION AT THIS TIME. ADDITIONAL INFORMATION PROVIDED IN H.3., H.6. AND H.11.

Additional Manufacturer Narrative

THE SAMPLE IS NOT AVAILABLE FOR RETURN, ALTHOUGH IMAGES WERE PROVIDED AND THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

Description of Event or Problem

A CUSTOMER REPORTED "THE BARB COULD NOT BE PUSHED BACK COMPLETELY. THE NEEDLE HAD TO BE REMOVED FROM THE PATIENT USING A SCALPEL. THIS INEVITABLY RESULTED IN TISSUE DAMAGE TO THE PATIENT. ONLY ONE NEEDLE FROM THE PACKAGE WAS AFFECTED. THE PRODUCT WAS DISPOSED OF." PHOTOS WERE PROVIDED.