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 01/05/2018

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Supplemental submitted to document device evaluation results.

Event Description

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

• 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7251535
• MDR Text Key: 99361721
• Report Number: 0001811755-2018-00395
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• 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: 02/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2007
• 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