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 05/25/2020

Event Type  malfunction  

Event Description

It was reported that during a surgical stapling operation utilizing brand-new leukoclip sd handle and cartridge, it was confirmed that the staple did not clip appropriately and the grabbed handle did not return to the initial position smoothly.The operation was completed with a new handle and a new cartridge.No patient harm.No information about delay.

Manufacturer Narrative

The product is not approved in the us.Therefore, under the regulations set forth under 21 c.F.R.§803, it is concluded that this is not a reportable event to the fda.

• 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: 10193680
• MDR Text Key: 196446172
• Report Number: 8043484-2020-00961
• Device Sequence Number: 1
• Product Code: MZR
• UDI-Device Identifier: 04582111152848
• UDI-Public: 4582111152848
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66047111
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1