MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALD; SURGICAL ADJUNCTS

Model Number EMERALDC30

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Lot number: unknown, as it was not provided.Expiration date: unknown, as lot number not provide.Unique identifier: unknown, as lot number not provide.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an explantable device.Device manufacture date: unknown, as lot number not provided.Attempts were made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there were five emerald30 cartridges that had ¿lips¿ on the distal end of cartridge.No further information was provided.This is 5 of 5 reports.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product could not be performed since the cartridge lot number was not provided.Conclusion: based on the information provided; is not possible to determine an indication of a product quality deficiency and the reported issue could not be verified.Johnson and johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8582410
• MDR Text Key: 144152812
• Report Number: 2648035-2019-00537
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)100801(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1