MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 115 V AUTOPSY SAW; SAW, POWERED, AND ACCESSORIES

Catalog Number 0810000000

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2017

Event Type  malfunction  

Event Description

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

• Brand Name: 115 V AUTOPSY SAW
• 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: 6941127
• MDR Text Key: 89952059
• Report Number: 0001811755-2017-01930
• 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
• Report Date: 10/11/2017

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: 0810000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• 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