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 Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of their customer that the 3013, reflex tl, skin stapler with tissue lift, 35 wide, was initially being returned due to a shipping error.However, upon the warehouse¿s receipt of the returning device an invoice in the box found that the reason for return was not as previously reported.The invoice stated, ¿that the reflex stapler did not release tissue when stapler is released resulting in improper placement of staples along incision and jamming of stapler.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the 3013, reflex tl, skin stapler with tissue lift, 35 wide, was initially being returned due to a shipping error.However, upon the warehouse¿s receipt of the returning device an invoice in the box found that the reason for return was not as previously reported.The invoice stated, ¿that the reflex stapler did not release tissue when stapler is released resulting in improper placement of staples along incision and jamming of stapler.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 3013 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the device was returned with zero clips remaining.There appeared to be a loose object within the device.Performed a functional inspection, when pulling the trigger, the device catches and the metal pieces at the distal end are rubbing against one another.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.(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: 17850273
• Report Number: 3007305485-2023-00210
• Device Sequence Number: 6830802
• Product Code: FZQ
• UDI-Device Identifier: 10653405050605
• UDI-Public: (01)10653405050605(17)270913(30)6(10)202209145
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: 202209145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic