CODMAN DISPOS PERFORATOR
Received Jul 27, 2026
Report 3014334038-2026-00059 · MDR key 50024259
Device
Generic name
Disposable Perforator
Manufacturer
Integra Lifesciences MansfieldCatalog number
261221
Lot number
7550133
Product problems
- Fail-Safe Did Not Operate
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
A facility reported that when doing the second hole, the perforator (ID: 261221) did not disengage, causing a tear in the dura matter. The bleeding was controlled without difficulties, and the procedure was completed.- Is the motor electrically or pneumatically powered? "Electrically powered."- What is the brand of the motor used? "Medtronic."- Was the perforator properly assembled with the motor? "Yes."- Were the recommended tests performed between each hole? "Yes."- Was the approach angle perpendicular as specified in the Instructions for Use? "The approach angle was not strictly perpendicular". - Was constant downward pressure applied? Yes.
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.