MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE; CLIP, REMOVABLE (SKIN)

Catalog Number	3013
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, 3013, reflex tl, skin stapler with tissue lift, 35 wide, was being used during an unknown procedure on an unknown date when it was reported, ¿we are having issues with the skin staples recently and was wandering if we may have a bad batch.There have been several consultants complaining of the same issue saying they are not closing the skin on both sides just on one side.We have had issue post operatively too where the staples are coming loose and falling out.¿.Further assessment questioning found that the patients wound needed to be redressed due to a spoiled dressing from wound coming open from the staples falling out.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 3013, reflex tl, skin stapler with tissue lift, 35 wide, was being used during an unknown procedure on an unknown date when it was reported, ¿we are having issues with the skin staples recently and was wandering if we may have a bad batch.There have been several consultants complaining of the same issue saying they are not closing the skin on both sides just on one side.We have had issue post operatively too where the staples are coming loose and falling out.¿.Further assessment questioning found that the patients wound needed to be redressed due to a spoiled dressing from wound coming open from the staples falling out.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not being returned and the photographic evidence provided does not appear to verify the complaint; 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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 10 complaints, regarding 17 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised to always ensure trigger is fully closed and released to properly feed the next staple into position.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17825529
• Report Number: 3007305485-2023-00208
• Device Sequence Number: 2440890
• Product Code: FZQ
• UDI-Device Identifier: 00653405050608
• UDI-Public: (01)00653405050608
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Catalogue Number: 3013
• Device Lot Number: 202305194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic