MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER, 8 FOOT CORD "; SAW, POWERED, AND ACCESSORIES

Catalog Number 0840000000

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.

Event Description

The manufacturer received a letter stating that the customer was using the device when the patient was burned.Although requested, no additional information was provided regarding adverse consequences, surgical delay or medical intervention.

Event Description

The manufacturer received a letter stating that the customer was using the device when the patient was burned.Although requested, no additional information was provided regarding adverse consequences, surgical delay or medical intervention.

• Brand Name: CAST CUTTER, 8 FOOT CORD "
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7737013
• MDR Text Key: 115649338
• Report Number: 0001811755-2018-01550
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0840000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1