CODMAN DISPOS PERFORATOR
Received Jun 18, 2026
Report 3014334038-2026-00053 · MDR key 25547921
Device
Generic name
Disposable Perforator
Manufacturer
Integra Lifesciences MansfieldCatalog number
261221
Lot number
7483559
Product problems
- Fail-Safe Did Not Operate
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
A FACILITY REPORTED THAT THE AUTOMATIC CLUTCH MECHANISM DID NOT FUNCTION AS EXPECTED, AND THE CODMAN PERFORATOR (ID 261221) FAILED TO STOP AFTER PENETRATING THE PATIENT¿S SKULL. THE SURGEON DID NOT APPLY EXCESSIVE PRESSURE NEAR THE POINT OF PERFORATION, AND NO SERIOUS INJURY RESULTED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. THE PERFORATOR WAS USED WITH A MEDTRONIC MIDAS REX ELECTRIC DRILL. THE PERFORATOR CLICKED INTO PLACE IN THE DRILL. THE RECOMMENDED SPRING TESTS WERE NOT PERFORMED BETWEEN EACH BURR HOLE. THE ANGLE OF APPROACH WAS MAINTAINED PERPENDICULAR, WITH NO ROCKING MOTION, AND CONSTANT DOWNWARD PRESSURE WAS APPLIED.