ROHS MICROSENSOR BASIC KIT

Report

Report Number: 1226348-2017-10792
Event Type: Injury
Date Received: October 26, 2017
Date of Event: October 9, 2017
Manufacturer: CODMAN & SHURTLEFF, INC.
Product Code: GWM
PMA / PMN Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

THE SENSOR WAS RETURNED FOR EVALUATION BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS FOUND THAT THE COMPONENT MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. A REVIEW OF FINISHED GOOD MANUFACTURING RECORDS WAS NOT POSSIBLE, AS NO LOT NUMBER WAS PROVIDED. EVALUATION OF THE RETURNED SENSOR FOUND THE INTERNAL WIRES WERE BROKEN AT THE CONNECTOR STRAIN RELIEF. THE CATHETER MATERIAL WAS SEVERELY KINKED AT THE CONNECTOR, INSIDE THE STRAIN RELIEF. DUE TO THE CONDITION OF THE SENSOR AS RECEIVED, NO FUNCTIONAL TESTING WAS POSSIBLE. BASED ON THEIR EVALUATION, THE SUPPLIER WAS ABLE TO CONFIRM THE REPORTED ISSUE AND DETERMINED THAT CAUSE OF FAILURE TO BE RELATED MISHANDLING OF THE DEVICE. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Additional Manufacturer Narrative · 1

(B)(4). THE 510(K) # OF SIMILAR PRODUCT CODE OF 826631: K914479. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

Description of Event or Problem · 1

AS REPORTED BY THE OUS AFFILIATE, A MICROSENSOR STOPPED WORKING POST OPERATIVELY. THE CATHETER WAS REMOVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
760618	ROHS MICROSENSOR BASIC KIT	DEVICE, INTRACRANIAL PRESSURE MONITORING	GWM	CODMAN & SHURTLEFF, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention