MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS FOOTSWITCH IPX7; UNIT, OPERATIVE DENTAL

Catalog Number	5100008000
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 2 events were reported for this quarter.Product return status: 1 device was received for evaluation.1 device was available for evaluation but has not yet been received.Evaluation status: 1 device evaluation is in progress.Additional information: there were no remedial actions taken.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had run-on.Two events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 2 total events were initially reported.2 previously reported events are included in this follow-up record.Product return status 2 devices were received.Evaluation status 2 reported events were confirmed during testing.- 1 device was found to be affected by corrosion.- 1 device was found to be affected by a deformed boot.  additional information 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had run-on.2 events had no patient involvement; no patient impact.

• Brand Name: TPS FOOTSWITCH IPX7
• Common Device Name: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7714814
• Report Number: 0001811755-2018-01205
• Device Sequence Number: 11080042
• Product Code: EIA
• UDI-Device Identifier: 04546540971272
• UDI-Public: 04546540971272
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: No Information
• Device Catalogue Number: 5100008000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1