FDA Adverse Event Death Summary report: N

CODMAN DISPOSABLE PERFORATOR

MDR report key: 4255880 · Received November 17, 2014

Report

Report Number: 1226348-2014-12103
Event Type: Death
Date Received: November 17, 2014
Date of Event: November 7, 2014
Manufacturer: CODMAN & SHURTLEFF, INC
Product Code: HBF
PMA / PMN Number: PK791101
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE EVALUATION REVEALED THAT THE CUSTOMER¿S COMPLAINT WAS NOT VERIFIED. THE CUSTOMER¿S PERFORATOR MET FUNCTIONAL TEST ACCEPTANCE REQUIREMENTS; PROPER ENGAGEMENT AND DISENGAGEMENT WAS ACHIEVED WITH EVERY DRILLED HOLE. BASED ON THE RESULTS OF THE INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

Additional Manufacturer Narrative · 1

(B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

(B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

Description of Event or Problem · 1

DISENGAGEMENT FAILURE. DURING THE CRANIOTOMY FOR THE PATIENT WITH AVM (B)(6), THE PERFORATOR COULD NOT STOP, WHICH CAUSED BRAIN CONTUSION AS WELL AS DURA INJURY. THE SURGEON REPORTED THAT THE DURA MATTER SEEMED TO BE PARTIALLY MELTED POSSIBLY DUE TO OVERHEAT OF THE TIP OF THE PERFORATOR. THE DEVICE HAD NOT BEEN REPROCESSED. AFTER THE SURGERY, THE PATIENT PASSED AWAY. THE SURGEON CONSIDERS THAT THE CAUSE OF THE DEATH IS BLEEDING DUE TO AVM, NOT THE BRAIN CONTUSION CAUSED BY THE PERFORATOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
743353	CODMAN DISPOSABLE PERFORATOR	DRILLS, BURRS, TREPHINES & ACC	HBF	CODMAN & SHURTLEFF, INC		GG016S

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Death