MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT DELUXE SKIN STAPLER 35W(30 EA), CA-5 BXS OF 6 EA; STAPLER, SKIN

Model Number	25-3003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "when the patient returned to office to have staples removed, 2 individual staples appeared to have broken off in the patient.The staples were not intact when removed.".
Additional Manufacturer Narrative
A user facility reported, " when the patient returned to office to have staples removed, 2 individual staples appeared to have broken off in the patient.The staples were not intact when removed." a supplier corrective action request (scar) has been sent to the (b)(4).Deroyal requested that the sample be returned, however the sample was discarded and could not be returned.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Additional Manufacturer Narrative
A supplier corrective action request (scar) has been sent to the stapler supplier, modern medical equipment.Deroyal requested that the sample be returned, however the sample was discarded and could not be returned.Deroyal completed a complaint to sales analysis from november 2021 to december 2023 and calculated it to be (b)(4).Modern medical equipment reviewed production records and drawings of staples and found no changes to design and no abnormalities in production.Each point of the manufacturing and inspection process were found to be controlled and in good condition.Lots of staples that were retained were inspected and tested.No abnormalities were found and the breaking of the staples could not be reproduced.Root cause: because review of production records and sample lot testing could not reproduce the problem, the root cause could not be determined.Corrective and preventive action: because no root cause could be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: DELUXE SKIN STAPLER 35W(30 EA), CA-5 BXS OF 6 EA
• Common Device Name: STAPLER, SKIN
• Manufacturer (Section D): MODERN MEDICAL EQUIPMENT; unit a, 10/f; mai wah ind.; bldg 1-7 wah sing street; kwai chung, new territories ; HK
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19951309
• Report Number: 1060680-2023-00014
• Device Sequence Number: 8923811
• Product Code: QQS
• UDI-Device Identifier: 00749756568197
• UDI-Public: 00749756568197
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25-3003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown