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

Catalog Number 5100004000

Device Problem Unintended Power Up (1162)

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

Event Date 06/24/2019

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: 3 events were reported for this quarter.Product return status: 1 device was received.1 device was not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by high impedance.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.

Event Description

This report summarizes 3 malfunction events in which the device ran without user activation.2 events had no patient involvement; no patient impact.1 event had no known impact or consequences to the patient.

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: 3 events were previously reported during the reporting period; however, - 1 event was reported in error.- 2 previously reported events are included in this follow-up record.Product return status 1 device was received.1 device was not available for evaluation.Event confirmation status 1 reported event was not confirmed.Evaluation results 1 device was found to be affected by high impedance.

Event Description

This report summarizes 2 malfunction events in which the device ran without user activation.1 events had no patient involvement; no patient impact.1 event had no known impact or consequences to the patient.

• Brand Name: TPS CORD
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8816405
• MDR Text Key: 152091650
• Report Number: 0001811755-2019-02432
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540970275
• UDI-Public: 04546540970275
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

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
• Device Operator: No Information
• Device Catalogue Number: 5100004000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1