MAUDE Adverse Event Report: LITEX MFG., INC. SKYTRON ; SURGICAL LIGHT ACCESSORY

Catalog Number B1-710-73

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2015

Event Type  Injury  

Event Description

The adapter for a skytron camera light that allows the use of a devon rigid disposable handle fell off during a case.It hit the back of the table.Sterile field needed to be reestablished for the case to proceed.No injuries were reported.The adapter is being returned for further evaluation.

• Brand Name: SKYTRON
• Type of Device: SURGICAL LIGHT ACCESSORY
• Manufacturer (Section D): LITEX MFG., INC.; glendale CA 91201
• Manufacturer (Section G): SKYTRON, DIV. THE KMW GROUP, INC.; 5000 36th st., s.e.; grand rapids MI 49512
• Manufacturer Contact: 5000 36th st., s.e.; grand rapids, MI 49512
• MDR Report Key: 5064408
• MDR Text Key: 25316715
• Report Number: 1825014-2015-00034
• Device Sequence Number: 1
• Product Code: FTA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: B1-710-73
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other