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

Model Number 25-3001

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

Root cause analysis: teleflex medical supplies the skin stapler (part number 25-3001) to deroyal.Therefore, a supplier corrective action request (scar) was submitted to teleflex.In its response to the scar, teleflex stated the true root cause cannot be determined.The actual sample in which the issue occurred was not returned for evaluation.A picture was provided for evaluation, but it is not possible to determine the root cause from the picture.A potential root cause has been identified as user error.The instructions for use (part number l03485) state the following: "contraindications: skin staples should not be used when it is impossible to maintain a 5 mm distance between stapled skin surface and underlying vessel, major nerves, internal organs, bones and connective tissue such as tendons and ligaments.Instructions for use: 1) skin eversion: use forceps or a tissue approximating device to approximate and evert the skin edges for staple placement.2) precock: precock the stapler by squeezing the handle until a slight resistance is felt and the staple is partially formed.Precocking allows more accurate staple placement.3) staple placement: place stapler jaws lightly on skin, or 1-2mm above skin, depending on the desired height of implanted staple above tissue.Center the jaw on the incision line and slowly squeeze trigger to place staple.To obtain optimum staple closure, the trigger must be squeezed all the way in.Visibility of staple placement is facilitated by the jaw design and staple sizing.Staple may be 'precooked' in any position (held in a partially closed position by the internal mechanism of the stapler).Allow a slight gap between the implanted staple top span in a skin surface to provide for easier staple removal." corrective action and/or systemic correction action taken: in its scar response, teleflex stated no corrective actions were taken because samples were not provided for evaluation and, therefore, a root cause not determined.Investigation summary: an internal complaint ((b)(4)) was received indicating that a skin stapler (part number 25-3001, lot number 73e1500522) had staples bending during use.The reported part number is a relabel item for deroyal; the finished good is supplied by teleflex medical.The qc complaint specialist reviewed the 2013-2015 scar and supplier notification letter (snl) logs for similar complaints.Similar complaints were identified for the failure mode of staples failing to form properly.Therefore, a scar was issued to the supplier and a response received 11/03/2015.The reporting customer supplied a photo of the reported failure, representative samples, labels for the reported lot number, and a hand-drawn diagram of the formation failures.The representative samples were returned to the qc complaint specialist for review on 10/12/2015.The representative samples were opened and from different lot numbers than the one reported.The staplers were test fired utilizing foam for resistance to identify if the staples fail to form.The reported failure could not be duplicated during this testing.In its scar response, teleflex stated the root cause could not be determined due to the lack of a sample for evaluation.In its scar response, teleflex indicated the device history record for the reported lot number was reviewed, but no quality issues were reported during manufacturing.The qc complaint specialist notified teleflex on 11/19/2015 that representative samples were available as well as a diagram of the formation failures by the reporting customer.If new information is received from teleflex, the complaint investigation will be reopened for updates.Preventive action: in its scar response, teleflex indicated no preventive actions were taken at this time because a root cause could not be determined without a sample available for evaluation.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

There were two surgeons that had issues with the staplers.The staples were bending during use.

• Brand Name: SKIN STAPLER 35W
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• 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: 5238789
• MDR Text Key: 32090956
• Report Number: 1060680-2015-00046
• 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
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• 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: 72E1500522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: No
• 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