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

Model Number 5100008000

Device Problem Device Remains Activated (1525)

Patient Problem No Patient Involvement (2645)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 4 events were reported for this quarter.Product return status: 4 device investigation types have not yet been determined.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed or reused.

Event Description

This report summarizes 4 malfunction events in which the device had run-on.4 events had no patient involvement; no patient impact.

Event Description

This report summarizes 3 malfunction events in which the device had run-on.3 events had no patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h10 4 events were previously reported during the reporting period; however, - 1 previously reported event in this report should have been included under device code of unintended power up (1162) and is reported in pr# 2377912.- 3 previously reported events are included in this follow-up record.Product return status 3 devices were received.Event confirmation status 1 reported event was confirmed.2 reported events were not confirmed.Evaluation results 2 devices were found to be affected by a damaged cable.1 device was found to be affected by a corroded connector.

• Brand Name: FOOTSWITCH
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9636736
• MDR Text Key: 177374919
• Report Number: 0001811755-2020-00227
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540971272
• UDI-Public: 04546540971272
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5100008000
• Device Catalogue Number: 5100008000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1