FDA Adverse Event Malfunction Summary report: N

T4 HOOD

MDR report key: 2955717 · Received February 11, 2013

Report

Report Number: 0001811755-2013-00228
Event Type: Malfunction
Date Received: February 11, 2013
Date of Event: January 24, 2013
Report Date: January 24, 2013
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: FYA
PMA / PMN Number: K 993148
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DURING THE DEVICE EVALUATION, PACKAGING DAMAGE WAS DETERMINED TO BE A PROBABLE CAUSE FOR THE REPORTED HOLE IN THE PACKAGING. A NONCONFORMANCE WAS OPENED TO EVALUATE THE EVENT.THE HOOD WILL NOT BE RETURNED TO THE USER FACILITY, AS IT NOT A REPAIRABLE PRODUCT.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

Description of Event or Problem · 1

UPON FOLLOW UP THE USER FACILITY REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE, A SMALL OPENING SLIGHTLY BIGGER THAN A PIN HOLE, NOT A HAIR, WAS FOUND IN THE STERILE PACKAGING OF THE HOOD. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN OPENING A PACKAGE PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, A HAIR WAS FOUND IN THE STERILE PACKAGING OF THE HOOD. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
59124	T4 HOOD	GOWN, SURGICAL	FYA	STRYKER INSTRUMENTS-KALAMAZOO		12112067

Patients

Seq	Age	Sex	Outcome	Treatment
1