MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 POWER PACK; ACCESSORY, SURGICAL APPAREL

Catalog Number 0400650000

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2014

Event Type  malfunction  

Event Description

It was reported that during charging conducted at the user facility the device was distorted from heat.No medical intervention and no adverse consequences were reported with this event.As this event occurred during charging, there was no patient involvement and no delay to a surgical procedure.

Manufacturer Narrative

The device was not returned for analysis; it is not possible to perform a device evaluation without return of the device.It was reported that the device was discarded by the user facility.

• Brand Name: T4 POWER PACK
• Type of Device: ACCESSORY, SURGICAL APPAREL
• 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: 3735806
• MDR Text Key: 4276679
• Report Number: 0001811755-2014-01241
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0400650000
• Device Lot Number: 13224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2013
• 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