T5 LT WT FIBER OPT SURG HELMET

Report

Report Number: 0001811755-2013-01623
Event Type: Malfunction
Date Received: July 11, 2013
Date of Event: June 18, 2013
Report Date: June 18, 2013
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: FXZ
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS.

Additional Manufacturer Narrative · 1

DURING THE DEVICE EVALUATION, IT WAS DETERMINED THAT HEAT BUILD-UP FROM A DAMAGED FIBER OPTIC CABLE WAS A PROBABLE CAUSE OF THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED TO THE USER FACILITY, AS IT IS NOT A REPAIRABLE DEVICE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE FIBER OPTIC CABLE PLUG WAS FOUND TO BE MELTED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE FIBER OPTIC CABLE PLUG WAS FOUND TO BE MELTED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
321113	T5 LT WT FIBER OPT SURG HELMET	HELMET, SURGICAL	FXZ	STRYKER INSTRUMENTS-KALAMAZOO

Patients

Seq	Age	Sex	Outcome	Treatment
1