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

Model Number 5100004000

Device Problem Device Remains Activated (1525)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2019

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: 3 device investigation types have not yet been determined.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed or reused.

Event Description

This report summarizes 3 malfunction events in which the device had run-on.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 reported event was not confirmed.Evaluation results: 1 device was found to be affected by an electrical problem.

Event Description

This report summarizes 3 malfunction events in which the device had run-on.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: h10 3 previously reported events are included in this follow-up record.Product return status 1 device was received.1 device was not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status 1 reported event was not confirmed.Evaluation results 1 device was found to be affected by a bias current warning.

Event Description

This report summarizes 3 malfunction events in which the device had run-on.3 events had no patient involvement; no patient impact.

• Brand Name: STANDARD CABLE
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9245335
• MDR Text Key: 174514316
• Report Number: 0001811755-2019-03453
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540970275
• UDI-Public: 04546540970275
• 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: 10/28/2020

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: No Information
• Device Model Number: 5100004000
• Device Catalogue Number: 5100004000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 09/30/2019
• Supplement Dates FDA Received: 04/28/2020; 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1