MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V. SKIN STAPLER 35W; STAPLER, SURGICAL

Model Number 25-3001

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary a medwatch report (uf report #4200070000-2020-8006) was received indicating that a skin stapler (25-3001) malfunctioned during use.Specifically, it was indicated that multiple staples fell out of the device onto the patient.This report was entered as an internal complaint (call 50999).A sample was received (b)(6) 2020 for evaluation.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The stapler is supplied to deroyal by teleflex.A supplier corrective action request (scar) was issued to teleflex.Additionally, the returned sample was forwarded to the supplier for evaluation.As of the date of this report, a response to the scar has not been received.Since (b)(6) 2018, 9,840 units have been sold.During the same period, 6 complaints were received for this part, yielding a complaint-to-sales ratio of 0.00061.One like complaint was identified.The investigation is incomplete at this time.When new and critical information is received, this report will be updated.

Event Description

While using the stapler to close the patient's surgical incision, multiple staples fell out of the staple gun onto the patient.

Event Description

While using the stapler to close the patient's surgical incision, multiple staples fell out of the staple gun onto the patient.

Manufacturer Narrative

Root cause: the stapler is supplied to deroyal by modern medical manufacturing.Therefore, a supplier corrective action request (scar) was issued to modern medical.In its response, modern medical stated two retained samples were checked and found to be working correctly after a firing test and simulated test on pig skin.A review of production records also found the incoming inspection, production process, and quality inspections were under controlled conditions.No nonconformances were found.Modern medical suspects this is an isolated case, and the root cause may be that the staple was not well caught during the firing process.Corrective action: a corrective action has not been taken.Investigation summary: a medwatch report (uf report #4200070000-2020-8006) was received indicating that a skin stapler (25-3001) malfunctioned during use.Specifically, it was indicated that multiple staples fell out of the device onto the patient.This report was entered as an internal complaint (call 50999).A sample was received september 25, 2020 for evaluation.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The stapler is supplied to deroyal by teleflex.A supplier corrective action request (scar) was issued to modern medical manufacturing.Additionally, the returned sample was forwarded to the supplier for evaluation.A response was received and accepted by deroyal personnel on october 9.Since september 2018, (b)(4) units have been sold.During the same period, 6 complaints were received for this part, yielding a complaint-to-sales ratio of 0.00061.One like complaint was identified.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Manufacturer Narrative

Root cause: the stapler is supplied to deroyal by teleflex.Therefore, a supplier corrective action request (scar) was issued to teleflex.In its response, teleflex stated the returned stapler was disassembled because the assembly between the cover top and cover bottom was not welded properly.Corrective action: the process in the manufacturing line was evaluated to determine what type of fixture would be most appropriate to improve the welding process.After evaluation, it was determined the fixture used to place the parts to be welded could be improved.It was decided to implement some sensors in the fixture and create a technique to ensure all parts are welded correctly.This will ensure the method will always be the same.Investigation summary.A medwatch report (uf report #(b)(4)) was received indicating that a skin stapler (25-3001) malfunctioned during use.Specifically, it was indicated that multiple staples fell out of the device onto the patient.This report was entered as an internal complaint (call (b)(4)).A sample was received september 28, 2020 for evaluation.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The stapler is supplied to deroyal by teleflex.A supplier corrective action request (scar) was issued to teleflex.Additionally, the returned sample was forwarded to the supplier for evaluation.A response was received and accepted by deroyal personnel on october 9.Since september 2018, (b)(4) units have been sold.During the same period, 6 complaints were received for this part, yielding a complaint-to-sales ratio of (b)(4).One like complaint was identified.Preventive action: the production line was monitored, and no similar defects were found.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

While using the stapler to close the patient's surgical incision, multiple staples fell out of the staple gun onto the patient.

• Brand Name: SKIN STAPLER 35W
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V.; prolongacion mision eusebio ki; no. 1316, rancho el descanso; tecate, baja california 21478 ; MX 21478
• MDR Report Key: 10608613
• MDR Text Key: 209592821
• Report Number: 1060680-2020-00002
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 00749756024372
• UDI-Public: 00749756024372
• 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,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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: 73B2000290
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR