MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STANDARD CABLE; UNIT, OPERATIVE DENTAL

Catalog Number 5100004000

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2023

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 6 events were reported for this quarter.Product return status 1 device was received.4 devices were not available for evaluation.1 device investigation type has not yet been determined.Additional information 6 devices were not labeled for single-use.6 devices were not reprocessed or reused.

Event Description

This report summarizes 6 malfunction events in which the device reportedly overheated.- 2 events had no patient involvement; no patient impact.- 1 event had patient involvement; no patient impact.- 3 events had insufficient information received.

Event Description

This report summarizes (b)(4) malfunction events in which the device reportedly overheated.- (b)(4) events had no patient involvement; no patient impact.- (b)(4) event had patient involvement; no patient impact.- (b)(4) events had insufficient information received.

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: h6, h11.(b)(4) previously reported events are included in this follow-up record.Product return status (b)(4) device was received.(b)(4) devices were not available for evaluation.

• Brand Name: STANDARD CABLE
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18557622
• MDR Text Key: 333466104
• Report Number: 3015967359-2024-00288
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540970275
• UDI-Public: 04546540970275
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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 Catalogue Number: 5100004000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 12/31/2023
• Supplement Dates FDA Received: 04/29/2024
• 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
• Patient Sequence Number: 1