MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY REFLEX; CLIP, REMOVABLE (SKIN)

Catalog Number	8735
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised that when it is not possible to maintain at least 5 mm distance from the stapled skin to underlying bones, vessels, and internal organs, the use of staples for skin closure is contraindicated.Prior to inserting staple, confirm staple will be positioned free of other staples or obstructions.Firing a staple over another staple may result in tissue compression and risk of compromised healing or scarring.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the that 8735, reflex tl, skin stapler with tissue lift, 35 wide device was being used during a closure of a laceration procedure on approximately (b)(6) 2025 when it was reported ¿staple gun jammed.There was no patient injury.Just a small delay in the procedure.Gun was disposed of.¿.Further assessment questioning found that ¿it got stuck in his head and the provider had to pry the device off.".The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: REFLEX
• Common Device Name: CLIP, REMOVABLE (SKIN)
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 22410604
• Report Number: 3007305485-2025-00107
• Device Sequence Number: 8352860
• Product Code: FZQ
• UDI-Device Identifier: 20653405037016
• UDI-Public: (01)20653405037016(17)290731(10)202408014
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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 Catalogue Number: 8735
• Device Lot Number: 202408014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic