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

Catalog Number	8735
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
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
A sales representative reported on behalf of a customer that the 8735, reflex tl, skin stapler with tissue lift, 35 wide device was being used during a scalp laceration repair on (b)(6) 2024, and ¿the stapler did not release once in the patient's scalp¿.Through follow-up assessment, the physician stated: ¿i had to remove the staples that stuck to the scalp and stapler because they stapled to high above the scalp.I had to trigger the stapler again to release the first one and then the second one did the same thing and i had to jiggle and move around the stapler to release the second one.Eventually after manipulation and moving around the stapler while still in the scalp it released.Out of the 4 that was deployed i had to remove 2 of them before using the smaller stapler device¿.The physician described an outcome of injury due to the patient having "had more pain with moving around the stapler device stuck to the scalp.He had some bleeding from the manipulation that was able to be stopped with pressure.".There was no reported delay and no report of medical/surgical intervention, or extended hospitalization for the patient or user.The patient¿s condition is ¿stable¿.This report is being raised on the basis of the reported injury of pain and bleeding.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 the following: 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the 8735, reflex tl, skin stapler with tissue lift, 35 wide device was being used during a scalp laceration repair on (b)(6) 2024, and ¿the stapler did not release once in the patient's scalp¿.Through follow-up assessment, the physician stated: ¿i had to remove the staples that stuck to the scalp and stapler because they stapled too high above the scalp.I had to trigger the stapler again to release the first one and then the second one did the same thing and i had to jiggle and move around the stapler to release the second one.Eventually after manipulation and moving around the stapler while still in the scalp it released.Out of the 4 that was deployed i had to remove 2 of them before using the smaller stapler device¿.The physician described an outcome of injury due to the patient having "had more pain with moving around the stapler device stuck to the scalp.He had some bleeding from the manipulation that was able to be stopped with pressure." there was no reported delay and no report of medical/surgical intervention, or extended hospitalization for the patient or user.The patient¿s condition is ¿stable¿.This report is being raised on the basis of the reported injury of pain and bleeding.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19447222
• Report Number: 3007305485-2024-00082
• Device Sequence Number: 3239901
• Product Code: FZQ
• UDI-Device Identifier: 00653405037012
• UDI-Public: (01)00653405037012
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8735
• Device Lot Number: 202304135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic