INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

Description of Event or Problem

INITIALLY RECEIVED INFORMATION: PLANNED PROCEDURE: PROSTATE LASER ENUCLEATION. PROBLEMS ENCOUNTERED: THE BROKEN INNER SHEATH OF THE RESECTOR SCOPE REMAINED IN THE BLADDER. ENUCLEATION PROCEDURE WITHOUT DIFFICULTY. THE INNER SHEATH MAY HAVE PRESENTED A PROBLEM AT THE BEGINNING OF THE PROCEDURE BECAUSE THE BACK LIGHT SOURCE SEEMED TO BE SLIGHTLY DEFLECTED IN ROTATION. NO PROBLEM TO NOTE UNTIL THE REMOVAL OF THE RESECTOR BEFORE MORCELLATION. UPON REMOVAL OF THE RESECTOR SCOPE, THE ABSENCE OF THE BACK LIGHT WAS NOTED. EXAMINATION OF THE RESECTOR SCOPE SHOWS THAT THE INNER SHEATH IS IN FACT BROKEN ALONG ALMOST ITS ENTIRE LENGTH DOWNSTREAM OF THE ZONE OF ATTACHMENT TO THE OUTER SHEATH. IT IS IMPOSSIBLE TO REMOVE THIS SHEATH ENDOSCOPICALLY WITH FORCEPS BECAUSE THE END IS VERY SHARP AND THERE IS A RISK OF DAMAGING THE URETHRA. THEREFORE, A CONVERSION WITH A MINI BLADDER SIZE IS DECIDED. ENDOSCOPY COMPLETED IN LAPAROSCOPY. THE PATIENT IS FINE. FURTHER INFORMATION RECEIVED: A BLADDER INCISION HAD TO BE MADE WHEN THE PROCEDURE WAS NATURAL. THE PROCEDURE WAS EXTENDED BY ONE HOUR. NO ADDITIONAL HOSPITALIZATION WAS NECESSARY.