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 3 events is as follows: cartridge tip cracked/damaged : 3.Section d4: serial number of the suspect product: ch08445: 3.0 investigations were completed, and 3 investigations are pending from this period.A review of the records related to the device including complaint trend and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained then a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

This report summarizes 3 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 are 2 investigations completed during this period.Breakdown of 2 completed investigations: 2 no product returned.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.That was received during the time period that covers this voluntary malfunction summary report has been submitted.

Manufacturer Narrative

Additional information: there is 1 additional investigation completed during this period.Breakdown of 1 completed investigation: 1 cartridge crack, cartridge tip cracked/damaged, override.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.That was received during the time period that covers this voluntary malfunction summary report has been submitted.

• 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: 11256529
• MDR Text Key: 242020438
• Report Number: 2648035-2021-00022
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PSCST30
• Patient Sequence Number: 1