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

Catalog Number 5100004000

Device Problem Overheating of Device (1437)

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

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). Two (2) events were reported for this quarter. Two (2) devices were received. One (1) device was not able to be evaluated for the reported event as there was a short in the device. One (1) device evaluation is in progress. 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 two (2) malfunction events in which the device reportedly overheated. One (1) event had no patient involvement; no patient impact. One (1) event had patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program. 1 device was received. The reported event was not duplicated during testing for 1 device; however, the device was outside specifications. 1 device was found to be affected by an electrical problem. 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 2 malfunction events in which the device reportedly overheated. 1 event had no patient involvement; no patient impact. 1 event had patient involvement; no patient impact.

• Brand Name: TPS CORD
• 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7219272
• Report Number: 0001811755-2018-00096
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 5100004000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse