MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number LT200

Device Problems Component Falling (1105); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

Opening the box with lt200 ligaclip the nurse see that one of the cartridges has fallen out of the sterile packing.It looks as if the paper and the soft plastic has separated and only holds together at the bottom of the glue line.The lt200 cartridge has fallen out of the sterile packaging laying loose in the carton bx.There were no patient consequences.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7477204
• MDR Text Key: 107197829
• Report Number: 3005075853-2018-09478
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20705036012808
• UDI-Public: 20705036012808
• Combination Product (y/n): N
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: LT200
• Device Lot Number: P4T44X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2018
• Date Device Manufactured: 10/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1