MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SRHS HEART TRACECART; GENERAL SURGERY TRAY (KIT)

Catalog Number 53-1913

Device Problems Mechanical Problem (1384); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary an internal complaint (b)(4) was received indicating that a clip applier (raw material 55-51395) contained within an srhs heart tracecart (finished good 53-1913) was misfiring during use.The raw material is supplied to deroyal by (b)(4).A supplier corrective action request (scar) was issued june 22, 2016, to (b)(4) and is due august 4, 2016.A response has not been received at this time.A sample was returned and received june 28, 2016.This sample has been forwarded to (b)(4) for evaluation.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.None were identified prior to the reporting customer filing two reports.The investigation is ongoing at this time.If new and critical information is received, this report will be updated.

Event Description

The clip appliers in the deroyal custom packs misfired.The incident occurred during use in an open heart procedure.

Manufacturer Narrative

Root cause: the clip applier contained within the finished good kit is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was submitted to (b)(4).In its scar response, (b)(4) reported that no damage was found in the external components.In an attempt to replicate the reported incident, the instrument was cycled, and it fed and formed 11 conforming clips and then ejected two clips.The device then locked out as intended.According to (b)(4) response, the device was disassembled to evaluate the condition of the internal components and no anomalies were found.Therefore, a conclusion could not be reached as to what may have caused the reported incident.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint ((b)(4)) was received indicating that a clip applier (raw material (b)(4)) contained within an srhs heart tracecart (finished good (b)(4)) was misfiring during use.The raw material is supplied to deroyal by (b)(4).A supplier corrective action request (scar) was issued june 22, 2016, to (b)(4) and the returned sample forwarded to the supplier for evaluation.(b)(4) responded to the scar on august 5, 2016.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.None were identified prior to the reporting customer filing two reports.Deroyal will continue to monitor postmarket feedback and will recognize in the future if the reported issue becomes recurring.Preventive action: due to the root cause determination, a preventive action has not been taken.The investigation is complete.If new and critical information is received, this report will be updated.

Event Description

The clip appliers in the deroyal custom packs misfired.The incident occurred during use in an open heart procedure.

• Brand Name: SRHS HEART TRACECART
• Type of Device: GENERAL SURGERY TRAY (KIT)
• 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 Key: 5797957
• MDR Text Key: 49640987
• Report Number: 3005011024-2016-00016
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 53-1913
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1