BROOKS DILATOR SET
Received Apr 16, 2025 · Event occurred Mar 3, 2025
Report 2125050-2025-00614 · MDR key 21850790
Device
Generic name
Corpus Cavernosum Dilator, Reusable
Manufacturer
Coloplast A/sProduct problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ACCORDING TO AVAILABLE INFORMATION, DOCTOR WAS USING A MENTOR BROOKS DILATOR DURING A BOSTON SCIENTIFIC IPP PROCEDURE. THE #12 HEAD OF THE DILATOR BROKE OFF IN THE PATIENT'S PROXIMAL CORPORA. THE DOCTOR WAS ABLE TO SUCCESSFULLY REMOVE THE BROKEN PIECE FROM THE PATIENT. THE COLOPLAST TM BELIEVES THE UNIT WAS REPROCESSED GREATER THAN 75 TIMES AND NOTED THE TIP WAS WELDED ON (VERSUS MOLDED LIKE THE CURRENT DILATOR DESIGN). THE COLOPLAST TM INDICATED THE DILATOR REFERENCED "MENTOR" AND THE END WAS WELDED INTO PLACE. THE DRAWING FOR THIS DEVICE WAS MADE OBSOLETE IN 2015. THE ¿MENTOR¿ NAME WAS CHANGED TO "COLOPLAST" IN 2007. IT WAS SUSPECTED THAT THIS DEVICE IS CLOSE TO 20 YEARS OLD, AND IT MAY HAVE BEEN REPROCESSED IN AN AUTOCLAVE OVER THE 75 TIMES SPECIFIED ON OUR CURRENT DILATOR. AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DILATOR BROKE OFF IN THE PATIENT'S PROXIMAL CORPORA. THE DOCTOR WAS ABLE TO SUCCESSFULLY REMOVE THE BROKEN PIECE FROM THE PATIENT. IT'S BELIEVED THE UNIT WAS REPROCESSED GREATER THAN 75 TIMES.
Additional Manufacturer Narrative
AS NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES 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.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DILATOR BROKE OFF IN THE PATIENT'S PROXIMAL CORPORA. THE DOCTOR WAS ABLE TO SUCCESSFULLY REMOVE THE BROKEN PIECE FROM THE PATIENT. IT'S BELIEVED THE UNIT WAS REPROCESSED GREATER THAN 75 TIMES.