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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Additional information: all events of cartridge tip cracked or damaged were related to tip deformed.Products have not been returned.Lot numbers of suspect products.Cd04808 quantity 7.Unknown quantity 2.Cd07065.Seven investigations out of the 10 were completed and they concluded the 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.
 
Event Description
This report summarizes 10 malfunction events.The events were related to cartridge tip cracked or damaged.There were no patient injuries reported associated to the events.
 
Manufacturer Narrative
Additional information: there were 2 investigations completed during this period.Both products were returned and all the tip was observed deformed.No manufacturing issues were identified.
 
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 (b)(4) and capa (b)(4).
 
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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 Key8563645
MDR Text Key144943205
Report Number2648035-2019-00512
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
PMA/PMN Number
K081545
Number of Events Reported10
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 Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received10/25/2020
Patient Sequence Number1
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