MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DEVON; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number SBA13AMNTJ

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/06/2019

Event Type  malfunction  

Event Description

During operating room procedure, it was discovered that disposable light handle covers were split in several places.

• Brand Name: DEVON
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; building 5; mansfield MA 02048
• MDR Report Key: 9409574
• MDR Text Key: 169058972
• Report Number: 9409574
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SBA13AMNTJ
• Device Lot Number: 309047
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2019
• Type of Device Usage: N
• Patient Sequence Number: 1