MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO OSCILLATING SAW; UNIT, OPERATIVE DENTAL

Catalog Number 5100031000

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

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.2 device investigation types have not yet been determined.  event confirmation status: 1 device evaluation is still in progress.  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 reportedly overheated.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 3 previously reported events are included in this follow-up record.Product return status 1 device was received.2 devices were not available for evaluation.Event confirmation status 1 evaluation is still in progress.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.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: 3 previously reported events are included in this follow-up record.Product return status 3 devices were not available for evaluation.Device not returned.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.

• Brand Name: TPS MICRO OSCILLATING SAW
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8546013
• MDR Text Key: 145114601
• Report Number: 0001811755-2019-01358
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540977748
• UDI-Public: 04546540977748
• 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,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100031000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1