MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CASTVAC - MOBILE STAND 100-120V (8 FT HOSE); SAW, POWERED, AND ACCESSORIES

Catalog Number 0986000000

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2017

Event Type  malfunction  

Event Description

It was reported that the device was sparking at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Event Description

It was reported that the device was sparking at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: CASTVAC - MOBILE STAND 100-120V (8 FT HOSE)
• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7174478
• MDR Text Key: 96703390
• Report Number: 0001811755-2018-00029
• 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: 10/01/2018

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: 12/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• Supplement Dates FDA Received: 10/01/2018
• 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