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

Catalog Number 0810000000

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

It was reported that during an autopsy at the user facility the device was sparking.No medical intervention and no adverse consequences were reported with this event.As this event occurred during an autopsy, there was no patient involvement and no delay to a surgical procedure.

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Manufacturer Narrative

The event of sparking was not duplicated; however, the device running and mixing with bodily fluids in combination with observed corrosion and debris could cause this event.The device was scrapped.

Event Description

It was reported that during an autopsy at the user facility the device was sparking.No medical intervention and no adverse consequences were reported with this event.As this event occurred during an autopsy, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: AUTOPSY SAW 115V
• 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: 4769311
• MDR Text Key: 17332363
• Report Number: 0001811755-2015-01740
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2015

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: 04/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2014
• 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