FDA Adverse Event Malfunction Summary report: N

T5 LT WT FIBER OPT SURG HELMET

MDR report key: 3931228 · Received July 14, 2014

Report

Report Number: 0001811755-2014-02491
Event Type: Malfunction
Date Received: July 14, 2014
Date of Event: June 17, 2014
Report Date: June 17, 2014
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: FXZ
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED. THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED.

Additional Manufacturer Narrative · 1

THE REPORTED OVEREATING WAS NOT ABLE TO BE DUPLICATED, NOR WAS EVIDENCE OF OVERHEATING FOUND ON THE DEVICE DURING VISUAL INSPECTION. HOWEVER, DURING DEVICE EVALUATION IT WAS NOTED THAT THE SHEATH OF THE FIBER OPTIC CABLE WAS TORN, WHICH CAN LEAD TO HEAT GENERATION. THE CORD IS NOT A REPAIRABLE DEVICE AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

Description of Event or Problem · 1

IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE OVERHEATED. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE OVERHEATED. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
410843	T5 LT WT FIBER OPT SURG HELMET	HELMET, SURGICAL	FXZ	STRYKER INSTRUMENTS-KALAMAZOO

Patients

Seq	Age	Sex	Outcome	Treatment
1