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

Catalog Number 0400650000

Device Problem Leak/Splash (1354)

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

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

Device not available for return.

Event Description

It was reported that at the user facility the device was leaking acid.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: T4 POWER PACK
• Type of Device: HELMET, 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: 5022683
• MDR Text Key: 24673224
• Report Number: 0001811755-2015-03071
• Device Sequence Number: 1
• Product Code: FXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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