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: breakdown of 9 events are as follows: cartridge crack, lens damaged: 1, cartridge tip cracked/damaged, delivery issue, difficult to use, loading issues: 5, cartridge tip cracked/damaged, delivery issue, stuck in cartridge: 1, cartridge tip cracked/damaged, haptic damaged, override: 1, difficult to use, haptic detached: 1.Lot numbers of suspect products: unknown - 1, ce09758 - 1, ce07812 - 1, ce08960 - 1, ce08959 - 5.4 investigation was completed in this period.5 investigation are pending from this period.Breakdown of completed investigations are as follows: no product returned ¿ 1, cartridge crack, cartridge tip cracked/damaged ¿ 1, cartridge tip cracked/damaged, haptic detached, lens damaged ¿ 1, cartridge tip cracked/damaged - 1, 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 filed.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 9 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 (b)(4) and capa (b)(4).

Manufacturer Narrative

Additional information: device available for evaluation: yes.Section d10: returned to manufacturer on: 02/19/2020.Section h3: device returned to manufacturer: yes.There is 1 investigation completed during this period.Breakdown of 1 investigation with respective lot number ce08959 with quantity 5 was found to have cartridge tip cracked or damaged.The investigations concluded that product met manufacturing release criteria and no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.

• 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: 10003008
• MDR Text Key: 189147022
• Report Number: 2648035-2020-00393
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 9
• 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: 04/27/2020
• 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