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

Catalog Number 0986000000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

The device has not been received at the manufacturer for testing.The customer has chose to not send the device back to the manufacturer for a visual inspection.Customer has chose not to send in device for evaluation.

Event Description

It was reported that during testing conducted at the user facility that the power cord had exposed wires.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported event was not duplicated and no failures were confirmed as the product for this investigation was not available for evaluation.Based on previous similar cases, improper storage or use issues can cause or contribute to the reported event.The device was not shipped to the manufacturer for evaluation per the customers request.Customer declined to send product in for evaluation.

Event Description

It was reported that during testing conducted at the user facility that the power cord had exposed wires.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• 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: 5198071
• MDR Text Key: 30265161
• Report Number: 0001811755-2015-03986
• 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: 10/28/2015

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2006
• 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