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

Model Number PSCST30

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information: from the 6 events: cartridge crack, haptic damaged, tip deformed 2, haptic damaged, tip deformed 1, tip deformed 3.Lot numbers of suspect products: ce04908 4, ce03903 2.4 investigations were completed: no products were returned.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 6 malfunction events.The events were related to cartridge tip cracked or damaged.There were no patient injuries reported associated to the events.

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-010215.

Manufacturer Narrative

Additional information: there were 2 investigations completed during this period and in both the products were returned.Breakdown for both lot number observations are as follows: ce03903 tip deformed.Ce03903 tip deformed.The investigation it concluded that product 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.H3 other text : placeholder.

• Brand Name: SILVER
• 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: 9257920
• MDR Text Key: 178745672
• Report Number: 2648035-2019-01158
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 6
• 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: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• 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