MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS UNIDIRECTIONAL FOOTSWITCH; UNIT, OPERATIVE DENTAL

Catalog Number 5100007000

Device Problem Device Remains Activated (1525)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Five events were reported for this quarter.(b)(4) devices were received for evaluation.Four events were confirmed.(b)(4) devices were found to be affected by damaged components.(b)(4) devices were found to be affected by a migrated component.The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 5 malfunction events in which the device had run-on.Five reported events had no patient involvement; no patient impact.

• Brand Name: TPS UNIDIRECTIONAL FOOTSWITCH
• Type of Device: UNIT, OPERATIVE DENTAL
• 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7219259
• MDR Text Key: 98435405
• Report Number: 0001811755-2018-00093
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2018

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: No Information
• Device Catalogue Number: 5100007000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2017
• Initial Date FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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