CRANIAL PERFORATOR 12/15MM HUDSON SHANK
Received May 23, 2022
Report 9610612-2022-00130 · MDR key 14469115
Device
Generic name
Highspeed Power Systems
Manufacturer
Aesculap AgModel number
GB304RCatalog number
GB304R
Lot number
52450401
Product problems
- Power Problem
- Power Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GB304R - CRANIAL PERFORATOR 12/15MM HUDSON SHANK. ACCORDING TO THE COMPLAINT DESCRIPTION, THE TREPAN DID NOT STOP AFTER PIERCING THE SKULL. THE PATIENT HARM WAS UNKNOWN. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative
UPDATED: B5- PATIENT HARM UPDATED TO "NO HAZARD". ACCORDING TO OUR EVALUATION, THIS EVENT HAS BEEN RE-ASSESSED AND IS CONSIDERED NO LONGER REPORTABLE; SEVERITY AND FAILURE HAVE BEEN REDUCED.
Description of Event or Problem
CLARIFICATION: PATIENT HARM WAS UPDATED TO "NO PATIENT HAZARD".