MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information: from the 11 events 10 were related to tip deformed and 1 for cartridge damage, improperly loaded.Products have not been returned.Lot numbers of suspect products: cd10743, 1.Ce00313, 3.Unknown x2.Cd10200, 1.Cd11245, 1.Ce00078, x2.Cd11842, 1.6 investigations were completed: 3 products were not returned.3 tips were found deformed.In all the investigations it was concluded that products met manufacturing release criteria and no product deficiency was identified.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be file all pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.

Event Description

This report summarizes 11 malfunction events.The events were related to cartridge tip cracked or damaged.There were no patient injuries reported associated to the events.

Manufacturer Narrative

4 investigations were completed: 2 products were not returned as they were discarded: for one of them one tip was found deformed and for the other one the cartridge was found crack and the tip deformed.Both products documentation showed that they met manufacturing release criteria and based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.2 products were returned: products met manufacturing release criteria and no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f and g.4 date 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 nr-0148919 and capa:(b)(4).

• Brand Name: PLATINUM 1 SERIES
• 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: 8843129
• MDR Text Key: 152850647
• Report Number: 2648035-2019-00797
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 11
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• 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
• Patient Sequence Number: 1