MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. LEUKOCLIP SD CARTRIDGE 10W CTN 10; TOPICAL APROXIMATION SYSTEM

Catalog Number 66047114

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

It was reported that staples of the leukoclip don't slide down correctly in the cartridge, so it can't be used properly.It is unknown when this malfunction was discovered, but a back-up was available and the treatment continued with a small delay.No patient harm was reported.

Manufacturer Narrative

This 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 CARTRIDGE 10W CTN 10
• Type of Device: TOPICAL APROXIMATION 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: 10684996
• MDR Text Key: 211523927
• Report Number: 8043484-2020-03219
• Device Sequence Number: 1
• Product Code: MZR
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66047114
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1