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 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint (call (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 (b)(6).A supplier corrective action request (scar) was issued (b)(6) 2016, to (b)(6) and is due (b)(6) 2016.A response has not been received at this time.Two incidents of the reported issue occurred (first incident reported in report 3005011024-2016-00016), but the end user returned only one sample.This sample was forwarded (b)(6) 2016, 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 packaged within the finished good kit is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request was submitted to (b)(4).In its response, the supplier stated a true root cause is indeterminate due to the defective sample in which the issue occurred not being returned for evaluation.Corrective action: due to the investigation and root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint ((b)(4)) was received indicating that a clip applier ((b)(4)) contained within an srhs heart tracecart ((b)(4)) was misfiring during use.Two incidents of the reported issue occurred (first incident reported in report 3005011024-2016-00016).However, the end user returned a defective sample for the first incident (report 3005011024-2016-00016), but neither a lot number nor a defective sample were provided for the incident reflected within this report (report 3005011024-2016-00018).The reporting customer was contacted for additional information and provided the following, "the technician told me that (the clip applier) was very stiff and difficult to fire.It fired several times and then jammed.The surgeon 'forced' it to fire outside of the patient and then it worked.Like it 'unjammed' it.They discarded off the field at that time." (b)(4) supplies the clip applier.A scar was issued to (b)(4) and a response has been received.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 post market feedback for the reported issue and will recognize in the future if it becomes a recurring event.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete 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.

• 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: 5797966
• MDR Text Key: 49641273
• Report Number: 3005011024-2016-00018
• 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: 08/01/2016

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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2016
• 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
• Patient Sequence Number: 1