MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. GENERAL SURGERY TRAY; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 89-3623

Device Problems Mechanical Problem (1384); Device Issue (2379); Mechanical Jam (2983); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: 1) call 34231 was received indicating that finished good 89-3623, general surgery tray, lot number 38576363, contained a skin stapler that jammed after five staples were fired.2) the qc complaint specialist reviewed the work order for discrepancies that would have contributed to the reported issue.No discrepancies were identified.Lot mapping identified that finished good 89-3623, lot number 38576363, contained raw material (b)(4) skin stapler, lot number 1409050008.Modern medical supplied the raw material lot number.3) the qc complaint specialist reviewed the 2013 to present supplier corrective action requests (scar) and supplier notification letter (snl) logs for similar complaints.A total of (b)(4) similar complaints were identified for "jamming" related issues.Modern medical was issued (b)(4).Additional time will be necessary for modern medical to complete the scar response due to awaiting the sample for evaluation.The sample was sent to royal sterilization systems for decontamination prior to shipment to modern medical.Correction: a replacement has been provided on sales order (b)(4).Root cause analysis: the true root cause of the reported issue is undetermined at this time due to the sample evaluation being incomplete.The sample was returned as a potential contaminated device; therefore, decontamination is required prior to inspection.Corrective action and/or systemic correction action taken: due to the investigation and root cause determination, a corrective action has not been taken.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is incomplete at this time.This report will be updated when more information is available.

Event Description

The procedure was delayed by a few minutes.Stapler fired about five times before jamming up.

Manufacturer Narrative

Root cause analysis: the skin stapler within the finished good kit that is reported to have jammed is supplied to deroyal industries by modern medical.Therefore, a supplier corrective action request (scar) and the returned sample were forwarded to modern medical.In its scar response, modern medical stated it suspects the reported issue to be an isolated case caused by an improper staple filling operation.Modern medical stated it received the returned sample october 13, 2015, and found that two staples were jammed at the outlet.Two more staples were found lying on the cartridge.When the jammed staples were removed and the staples lying on the cartridge fixed, a firing test was performed during which the remaining staples formed correctly.Modern medical reported retained samples were checked as well and found to function properly.Corrective action: in its scar response, modern medical stated training was provided for operators to perform a self-check after filling the stapler to avoid staples lying on the cartridge.Investigation summary an internal complaint (call (b)(4)) was received indicating that a general surgery tray (finished good 89-3623, lot number 38576363) contained a skin stapler that jammed after five staples were fired.The skin stapler within the finished good kit is supplied to deroyal by modern medical.The reported finished good lot number contained raw material 25-3001cs, lot number 1409050008.A scar request and the returned sample were forwarded to modern medical.The 2013-2015 scar and supplier notification letter logs were reviewed for similar complaints.A total of 20 similar complaints were identified for "jamming" related issues.Due to the number of complaints received for skin stapler related issues, a corrective and preventive action (capa) investigation was opened to investigate the trend.The capa has been completed and verified.Deroyal will continue to track and trend complaints for further evaluation if additional actions are necessary.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 procedure was delayed by a few minutes.Stapler fired about five times before jamming up.

• Brand Name: GENERAL SURGERY TRAY
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central ave.; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central ave.; lafollette TN 37766
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5136862
• MDR Text Key: 27807041
• Report Number: 3005011024-2015-00009
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-3623
• Device Lot Number: 38576363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• 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