MAUDE Adverse Event Report: DESIGN STANDARDS CORP. SKIN STAPLER; STAPLE, REMOVABLE (SKIN)

Model Number 25-1001

Device Problems Misfire (2532); Firing Problem (4011)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary.An internal complaint (call 50723) was received for a skin stapler that did not close a surgical wound.Three packages of skin staplers were returned for evaluation.The complaint investigator opened one of these packs and activated the stapler into neoprene foam.No issue was detected, and the staplers worked as intended.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The product is supplied to deroyal by design standards corp.A supplier corrective action request (scar) was issued to the supplier due to the nature of the event.The two additional packs of staples that were returned by the customer were sent to the supplier for evaluation.As of the date of this report, a response has not been received.Since july 2018, there have been (b)(4) cases sold.There has been one complaint in that time frame, yielding a complaint-to-sales ratio of (b)(4).The investigation is incomplete at this time.When new and critical information is received, this report will be updated.

Event Description

A skin stapler was used to close a wound after surgery.The staples did not close the wound.

Event Description

A skin stapler was used to close a wound after surgery.The staples did not close the wound.

Manufacturer Narrative

Root cause: the product is supplied to deroyal by design standards corp.Therefore, a supplier corrective action request (scar) was issued to design standards.In its response, the supplier stated the results of the root cause analysis found no defects for the finished product from the reported lot.Two devices were returned and tested to the finished product testing standard.The devices were fired in air and in test media, and no defects were observed.The alleged defective device was not returned for analysis, and therefore, could not be analysed for the defect observed in the field.The potential cause for an incomplete staple formation has been observed when the device is not used as described in the instructions for use.If the user does not approximate the tissue using forceps and presses the stapler into the skin and underlying hard tissue or bone, the staple may not form completely.Corrective action: a corrective action has not been taken due to the root cause determination.Investigation summary an internal complaint ((b)(4)) was received for a skin stapler that did not close a surgical wound.Three packages of skin staplers were returned for evaluation.The complaint investigator opened one of these packs and activated the stapler into neoprene foam.No issue was detected, and the staplers worked as intended.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The product is supplied to deroyal by design standards corp.A scar was issued to the supplier due to the nature of the event.The two additional packs of staples that were returned by the customer were sent to the supplier for evaluation.A response was received and accepted september 11, 2020 by deroyal personnel.Since july 2018, there have been (b)(4) cases sold.There has been one complaint in that time frame, yielding a complaint-to-sales ratio of (b)(4).The investigation is complete at this time.If new and critical information is received, this report will be updated.

• Brand Name: SKIN STAPLER
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): DESIGN STANDARDS CORP.; 957 claremont rd; charlestown; nh NH 03603
• MDR Report Key: 10459409
• MDR Text Key: 204551871
• Report Number: 1060680-2020-00001
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-1001
• Device Lot Number: NH180619-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1