SPROTTE®

Description of Event or Problem

IRN# (B)(4). ORIGINAL TEXT / GERMAN: HERR DR. W WOLLTE EINE SPA STECHEN. DIES WAR FRUSTRAN. DIE ZIELSTRUKTUR WURDE NICHT ERREICHT. BEIM ZIEHEN DER NADEL IST DIESE GEBROCHEN UND CA. 5CM SIND IM PATIENTEN VERBLIEBEN. (DIE SECTIO ERFOLGTE IN VOLLNARKOSE OHNE PROBLEME) HERR R. W BESCHREIBT DIE PUNKTION OHNE JEDE PROBLEME ODER KNOCHENKONTAKT. WARUM DIE NADEL BEIM DURCHDRINGEN DER WEICHTEILE GEBROCHEN IST, IST VÖLLIG UNKLAR. TRANSLATED INTO ENGLISH: DR. W. WANTED TO PRICK A SPA. THIS WAS WITHOUT EFFECT . THE TARGET STRUCTURE WAS NOT REACHED. WHEN THE NEEDLE WAS PULLED OUT, IT BROKE AND APPROX. 5 CM REMAINED IN THE PATIENT. (THE SECTION WAS PERFORMED UNDER GENERAL ANAESTHESIA WITHOUT ANY PROBLEMS) MR. R. W. DESCRIBES THE PUNCTURE WITHOUT ANY PROBLEMS OR BONE CONTACT. IT IS COMPLETELY UNCLEAR WHY THE NEEDLE BROKE WHEN PENETRATING THE SOFT TISSUE.

Additional Manufacturer Narrative

EVENT TOOK PLACE IN GERMANY. THE FACTS OF THE CASE, RELEVANT TESTS ARE CURRENTLY IN PROCESS. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

Additional Manufacturer Narrative

EVENT TOOK PLACE IN GERMANY. BASED ON CLINICAL ASSESSMENT AND RISK ASSESSMENT THIS EVENT IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

Description of Event or Problem

IRN# (B)(4). TENTATIVE TRANSLATION TO ENGLISH: DR. (B)(6) WANTED TO PRICK A SPA. THIS WAS WITHOUT EFFECT. THE TARGET STRUCTURE WAS NOT REACHED. WHEN THE NEEDLE WAS PULLED OUT, IT BROKE AND APPROX. 5 CM REMAINED IN THE PATIENT. (THE SECTION WAS PERFORMED UNDER GENERAL ANAESTHESIA WITHOUT ANY PROBLEMS) MR. R. W. DESCRIBES THE PUNCTURE WITHOUT ANY PROBLEMS OR BONE CONTACT. IT IS COMPLETELY UNCLEAR WHY THE NEEDLE BROKE WHEN PENETRATING THE SOFT TISSUE.