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

Model Number 5100008000

Device Problem Unintended Power Up (1162)

Patient Problem No Patient Involvement (2645)

Event Date 12/31/2019

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: 1 previously reported event was included under mfr report # 0001811755-2020-00227 but should be included under this report.Product return status: 1 device was received.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by a damaged cable.

Event Description

This report summarizes 1 malfunction event in which the device ran without user activation.1 event had no patient involvement; no patient impact.

• Brand Name: FOOTSWITCH
• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 10011402
• MDR Text Key: 189591062
• Report Number: 0001811755-2020-01239
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540971272
• UDI-Public: 04546540971272
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5100008000
• Device Catalogue Number: 5100008000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2019
• 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