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

Catalog Number 5100004000

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Patient Involvement (2645)

Event Date 12/25/2018

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: 5 events were reported for this quarter.  product return status: 3 device was received.2 device investigation types have not yet been determined.Evaluation status: 1 reported event was not confirmed during testing; however: 1 device was found to be affected by an electrical short in the cable.In progress: 2 device evaluations are in progress.Additional information: 5 devices were not labeled for single-use.5 devices were not reprocessed and reused.

Event Description

This report summarizes 5 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.2 events had the patient receive a burn.

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: 5 previously reported events are included in this follow-up record.Product return status 4 devices were received.1 device investigation type has not yet been determined.Event confirmation status 1 reported events were not confirmed.3 evaluations are still in progress.Evaluation results 1 device was found to be affected by an electrical problem.

Event Description

This report summarizes 5 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.2 events had the patient receive a burn.

• 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: 8285452
• MDR Text Key: 134362236
• Report Number: 0001811755-2019-00314
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540970275
• UDI-Public: 4546540970275
• Combination Product (y/n): N
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100004000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1