MAUDE Adverse Event Report: MODERN MEDICAL SKIN STAPLER 35W; STAPLER, SURGICAL

Model Number 25-3001

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary; an initial complaint ((b)(4)) was received indicating that a skin stapler misfired during use.The end user reported there was no harm to the patient and the procedure was completed with another device.The defective sample was not available for return.The product is supplied to deroyal by (b)(4).Deroyal relabels and distributes the product.Therefore, a supplier corrective action request was issued to (b)(4).As of the date of this report, a response has not been received.This report will be updated when a response is received.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

A skin stapler misfired during procedure.The patient was not harmed, but this caused a slight increase in procedure time.The case was finished after opening another device.

Manufacturer Narrative

Root cause: a supplier corrective action request (scar) was issued to the manufacturer, modern medical.In its response, modern medical stated the failure mode reported could not be confirmed based on the information received.No samples were available, and therefore, it was not possible to determine the source of the reported defect.Corrective action: in its scar response, modern medical stated a corrective action would not be taken due to the root cause determination.An initial complaint (b)(4) was received indicating that a skin stapler misfired during use.The end user reported there was no harm to the patient and the procedure was completed with another device.The defective sample was not available for return.The investigator reviewed the purchase order for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The product is supplied to deroyal by modern medical.Deroyal relabels and distributes the product.Therefore, a scar request was issued to modern medical and a response has been received.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.Similar complaints for the item were identified.Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs.Preventive action: in its scar response, modern medical stated a preventive action would not be taken due to the root cause determination.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A skin stapler misfired during procedure.The patient was not harmed, but this caused a slight increase in procedure time.The case was finished after opening another device.

• Brand Name: SKIN STAPLER 35W
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): MODERN MEDICAL; dong xing industrial area; kang le lu, shan xia distric; heng li, dongguan guangdong, 52346 6; CH 523466
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 6463956
• MDR Text Key: 72188297
• Report Number: 1060680-2017-00010
• Device Sequence Number: 1
• Product Code: GAG
• 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
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-3001
• Device Lot Number: 73H1600260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2017
• 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
• Patient Sequence Number: 1