MAUDE Adverse Event Report: TELEFLEX MEDICAL DE MEXICO, S. DE R.I. DE C.V. AVE DEROYAL FIXED HEAD SKIN STAPLER; STAPLE, REMOVABLE (SKIN)

Catalog Number 25-3001CNS

Device Problems Mechanical Problem (1384); Misfire (2532); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

Dr.(b)(6) has complained several times regarding our new skin staplers (b)(4) that are in the c-section packs.When using them on most patients, the staples are wanting to pull out.

Manufacturer Narrative

Investigation findings: (b)(4) has been issued to modern medical for the reported issue.The scar due date is (b)(6) 2015.F/u on (b)(6) 2015 with the vendor to remind them of the approaching scar due date.When the report was filed, a lot number was not provided.The end user stated that they receive the product through a cardinal pack (b)(4).Deroyal supplies the stapler to cardinal for use within their packs.Rep samples may be available from the reporting customer.Root cause analysis: deroyal: the actual sample in which the issue occurred is not being returned for evaluation.A review of the fmea has identified potential root causes for the issue reported: end user error of not fully squeezing the handle and properly forming the samples and mechanical failure of the device.Investigation is incomplete at this time.This report will be updated if more info becomes available.

Manufacturer Narrative

The reporting customer supplied two unused samples.It is unable to be determined if the representative samples were from the same lot number as the reported defective devices.A total of 10 staples from each product was fired into a block of foam and formed as intended.No issues occurred during the evaluation of the product.The staplers with the remaining staples were forwarded to modern medical for evaluation on 03/27/2015.The vendor has evaluated the returned samples and provided an update to the initial scar response.(b)(4).Correction: replacements were provided on order# (b)(4).Root cause analysis: scar: the claimed issue from the complaint file seemed that the staples of the stapler did not form completely, so the staples could not firmly close the patient's skin during use.The incomplete forming of the staple might be caused by blocking of the staple due to improper assembling of the stapler components.As the defective sample and lot number involved were not obtained, a true root cause was not determined.Deroyal: the actual sample in which the issue occurred is not being returned for evaluation.A review of the fmea has identified the potential root causes for the issue reported: lend user error is not fully squeezing the handle and properly forming the staples and properly forming the staples, and mechanical failure of the device.Corrective action and/or systemic correction action taken: scar: training will be provided for the assembly operators of stapler to emphasize following the specified operation instructions to do the assembly of the stapler and self-check after assembly.Evidence of the training has been received and included in the scar response.Preventive action: scar a preventive action has not been taken.Investigation is complete at this time.This report will be updated when more information becomes available.

• Brand Name: DEROYAL FIXED HEAD SKIN STAPLER
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL DE MEXICO, S. DE R.I. DE C.V. AVE; industrias no 5954 parque industrial finsa; nueva laredo tamaulipas ; MX
• Manufacturer Contact: 200 debusk ln; powell, TN 37849 ; 8653626112
• MDR Report Key: 4641125
• MDR Text Key: 16563076
• Report Number: 1060680-2015-00005
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25-3001CNS
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2015
• 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