MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. LEUKOCLIP SD HANDLE; TOPICAL APPROXIMATION SYSTEM

Catalog Number 66047111

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Event Description

It was reported that during a surgical stapling operation with leukoclip sd handle and a cartridge, the staples became not to closed appropriately.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

H3, h6: the device used in treatment has been returned and evaluated establishing a relationship with the reported event.The visual and functional found no faults.Probable causes include set up and use of device.The instruction for use manual for leukoclip sd has been reviewed, it is very important for the proper functioning of the device that the handle before sliding the cartridge on is properly set by aligning the arrows.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: LEUKOCLIP SD HANDLE
• Type of Device: TOPICAL APPROXIMATION SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10411866
• MDR Text Key: 203083404
• Report Number: 8043484-2020-02520
• Device Sequence Number: 1
• Product Code: MZR
• UDI-Device Identifier: 04582111152848
• UDI-Public: 4582111152848
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66047111
• Device Lot Number: 678943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1