MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP FOOTSWITCH; UNIT, OPERATIVE DENTAL

Model Number 5100008000

Device Problems Unintended Power Up (1162); Device Remains Activated (1525)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

The user facility reported that the device continued to run during a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

The user facility reported that the device continued to run during a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: FOOTSWITCH
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16328732
• MDR Text Key: 309183640
• Report Number: 3015967359-2023-00384
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540971272
• UDI-Public: 04546540971272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032117
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5100008000
• Device Catalogue Number: 5100008000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2023
• 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