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

Catalog Number 0408800100

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

Device discarded at account.

Event Description

It was reported that after a surgical procedure at the user facility, the device was found to be expired.It was further reported that the sales rep provided the device to the user facility.It was further reported that there was no patient involvement, no delay in the procedure, no medical intervention required, and no adverse consequences associated with this event.

• Brand Name: FLYTE HOOD, 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: 6900917
• MDR Text Key: 87643649
• Report Number: 0001811755-2017-01897
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 4546540591722
• UDI-Public: (01)4546540591722
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1