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

Catalog Number 5100004000

Device Problems Device Alarm System (1012); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2019

Event Type  malfunction  

Event Description

The manufacturer sales representative reported that the device overheated while it was being tested at the user facility.There were no adverse consequences related to this event.

Manufacturer Narrative

It was determined after receiving further clarification from receipt of the device that this event was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify a mdr was not required for this event.The reported event was originally described as a handpiece overheating.Upon clarification of the event with the customer, the actual reported event was for a cable that was faulty and causing an error, no physical overheat reported.

Event Description

The manufacturer sales representative reported that the device overheated while it was being tested at the user facility.There were no adverse consequences related to this event.

• Brand Name: STANDARD CABLE
• 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: 8956650
• MDR Text Key: 156323377
• Report Number: 0001811755-2019-02891
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K032117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

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: Health Professional
• Device Catalogue Number: 5100004000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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