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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. MAJOR PACK GENERAL SURGERY TRAY

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DEROYAL INDUSTRIES, INC. MAJOR PACK GENERAL SURGERY TRAY Back to Search Results
Model Number 50-1895
Device Problems Crack (1135); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/28/2017
Event Type  Malfunction  
Manufacturer Narrative

Root cause: the light handle cover is a component contained within a convenience kit. The cover is contract manufactured to a specification. Therefore, a supplier corrective action request was issued to the contract manufacturer. A potential root cause of a defective cover was identified; however, inspection data showed no evidence of a fit failure. Corrective action: in its scar response, the supplier stated it shall continue to follow procedures outlined for inspection frequency of the product fit. It will continue to monitor product during manufacturing utilizing inspection plan and go/no-go gauges that are required for the product. Investigation summary: an internal complaint (call 40762) was received indicating that a light handle cover contained within a finished good pack (part number 50-1895) fell off a surgical light during a procedure and was cracked. A sample was not returned for evaluation. A lot number was not provided, and due to the absence of a reported lot number, the work order could not be reviewed for discrepancies that may have contributed to the reported event. The raw material component was identified as 4-9542-1. This component is contract manufactured, and a supplier corrective action request was issued to the contract manufacturer. A response was received and accepted may 24, 2017. Deroyal will continue to monitor post market feedback and will recognize in the future if the reported issue recurs. Preventive action: in its scar response, the supplier referred to its above stated corrective action. The investigation is complete at this time. If new and critical information is received, this report will be updated.

 
Event Description

A light handle cover that was packaged in a surgical tray convenience kit fell off and was cracked. The product was being used on a surgical light during a general surgical procedure.

 
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Brand NameMAJOR PACK
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
1501 east central avenue
lafollette TN 37766
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1501 east central avenue
lafollette TN 37766
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key6592652
MDR Text Key76054349
Report Number3005011024-2017-00008
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK842648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 05/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number50-1895
Device LOT NumberNOT PROVIDED
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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