MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE HOOD W/ PEELAWAY; GOWN, SURGICAL

Catalog Number 0408800100

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility lint was coming off the filter on top of the device.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that during a surgical procedure at the user facility, lint was coming off the filter on top of the device.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Manufacturer Narrative

The reported linting of the device was not able to be confirmed by a manufacturer repair technician through visual inspection.The product in question was not returned; however, a representative sample of the same lot number was evaluated and no failures were found related to the reported event.The hoods are not a repairable device and will therefore not be returned to the user facility.

• Brand Name: FLYTE HOOD W/ PEELAWAY
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3951724
• MDR Text Key: 4641009
• Report Number: 0001811755-2014-02621
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0408800100
• Device Lot Number: 14050698
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1