BROOKS DILATOR SET

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, A PERFORATION OCCURRED DURING DILATION. THE LEFT CORPORA WAS MEASURING 2,3 WHILE THE RIGHT WAS MEASURING AN EASY 25. WHEN GOING BACK WITH A 10 BROOKS DILATOR THE PERFORATION OCCURRED PROXIMALLY. A SUTURE SLING WAS ADDED TO LEFT CYLINDER THROUGH 1CM RT SINCE THE AREA WAS PERFORATED.

Additional Manufacturer Narrative

AS NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NON-CONFORMANCES AND CAPAS COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, BECAUSE EXAMINATION OF THE RETURNED COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PERFORATION, QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS. MEDICAL AFFAIRS REVIEWED THE COMPLAINT AND CONCLUDED IT WAS A PROCEDURAL COMPLICATION. THE PERFORATION OCCURRED RELATED TO NORMAL DEVICE USAGE. THERE WAS NO DEVICE MALFUNCTION REPORTED NOR WAS A DEVICE RETURNED FOR ANALYSIS. THERE IS NO INFORMATION IN FAVOR OF AN OFF-LABEL USE OR USE ERROR THAT COULD BE SUSPECTED. THE IFU INDICATES ADVERSE EVENTS ARE KNOWN TO OCCUR WITH SURGICAL PROCEDURES FOR PENILE PROSTHESIS. PERFORATION IS LISTED AS A POSSIBLE ADVERSE EVENT IN THIS PRODUCT'S IFU. BROOKS DILATORS ARE AVAILABLE IN MULTIPLE DIAMETERS TO ALLOW FLEXIBILITY OF VARIOUS ANATOMIES. AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED. OVERALL, THE OCCURRENCE RATE OF PERFORATIONS DURING USAGE OF THE BROOKS PRODUCT REMAINS LOW. CORRECTION: B2: UPDATED TO REQUIRED INTERVENTION. B5: DESCRIBE EVENT OR PROBLEM. A TYPOGRAPHICAL ERROR WAS NOTED IN THE VALUES REFERENCED ON THE INITIAL REPORT.

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, A PERFORATION OCCURRED DURING DILATION. THE LEFT CORPORA WAS MEASURING 23 WHILE THE RIGHT WAS MEASURING AN EASY 25. WHEN GOING BACK WITH A 10 BROOKS DILATOR THE PERFORATION OCCURRED PROXIMALLY. A SUTURE SLING WAS ADDED TO LEFT CYLINDER THROUGH 1CM RT SINCE THE AREA WAS PERFORATED. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, IT WAS AN UNEVENTFUL SURGERY INITIALLY AND CORPOROTOMIES WERE MADE IN THE USUAL FASHION. THERE WAS A SIZE DISCREPANCY BETWEEN THE LEFT AND RIGHT. FIELD GOAL TEST CONFIRMED THERE WAS SCAR TISSUE OR NARROWING OBSTRUCTING THE LEFT PROXIMAL CORPORA. A REPEAT DILATION WAS PERFORMED SEQUENTIALLY FROM 11 TO 14 MM. DURING THIS TIME A RIGHT PROXIMAL PERFORATION WAS NOTED AND CONFIRMED ON REPEAT FIELD GOAL TEST. THE LEFT CYLINDER WAS PLACED USING THE WINDSOCK TECHNIQUE AND OTHERWISE THE REMAINDER OF THE SURGERY WAS UNREMARKABLE. THE PATIENT WAS SENT HOME THE SAME DAY AND WAS STABLE AT TIME OF DISCHARGE.