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 09/16/2014

Event Type  malfunction  

Event Description

It was reported that sparks are coming from the cast vac during cast removal procedure.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, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Manufacturer Narrative

The reported event, hot smell and sparks came from it during use, was duplicated.Through functional testing, the service technician noted that the castvac was sparking inside of the canister.Upon disassembly, the technician visually identified non-stryker wiring as well as a non-stryker gasket.All non-conforming parts were replaced and the repaired device was returned to the customer.

Event Description

It was reported that sparks are coming from the cast vac during cast removal procedure.The procedure was completed successfully.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: 4168741
• MDR Text Key: 5090705
• Report Number: 0001811755-2014-03581
• 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: 09/16/2014

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: 09/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 10/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2014
• 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