MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS UNIVERSAL HANDSWITCH; UNIT, OPERATIVE DENTAL

Catalog Number 5100009000

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Sixteen devices were received for evaluation; sixteen events were confirmed during testing.Sixteen devices were found to be affected by illegible device labeling.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 16 malfunction events in which the device was found to have illegible run/safe etchings.Illegible run/safe etchings could potentially cause disorientation for the user, which may lead to unintentional running of the device.There was no patient involvement; no patient impact.

• Brand Name: TPS UNIVERSAL HANDSWITCH
• 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6279937
• MDR Text Key: 66135130
• Report Number: 0001811755-2017-00232
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 16
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100009000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2016
• 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