MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ELECTRIC HANDSWITCH- LEFT HANDED; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5400121000S1
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer service technician reported that the device overheated while it was being serviced at the manufacturer facility.There were no adverse consequences related to this event.

• Brand Name: ELECTRIC HANDSWITCH- LEFT HANDED
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8688339
• Report Number: 0001811755-2019-01996
• Device Sequence Number: 2372531
• Product Code: ERL
• UDI-Device Identifier: 07613154495634
• UDI-Public: 07613154495634
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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
• Operator of Device: Other
• Device Catalogue Number: 5400121000S1
• Device Lot Number: 18066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1