MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CASTVAC W/8 FOOT HOSE AND MOBILE STAND; SAW, POWERED, AND ACCESSORIES

Catalog Number 0986000000

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

It was reported that the cast vacuum is sparking during a procedure at the user facility.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 the cast vacuum is sparking during a procedure at the user facility.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device has been received, but the evaluation has not yet begun.Additional information may be submitted once the quality investigation is complete.

Manufacturer Narrative

The original reported event, sparks from the bottom of the canister, was confirmed.The service technician observed that the motor was loud and causing sparks in the bottom canister.The motor was replaced, device was repaired and returned to the customer after passing the final inspection.

• Brand Name: CASTVAC W/8 FOOT HOSE AND MOBILE STAND
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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: 3913311
• MDR Text Key: 4580576
• Report Number: 0001811755-2014-02392
• Device Sequence Number: 1
• Product Code: HAB
• 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,Followup
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0986000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 07/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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