MAUDE Adverse Event Report: SCITON, INC. YAG LASER/SCITON COOLING UNIT; POWERED LASER SURGICAL INSTRUMENT

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2020

Event Type  malfunction  

Event Description

Yag laser/sciton cooler was utilized during surgical case.It was noted that the device was not cooling as intended.

• Brand Name: YAG LASER/SCITON COOLING UNIT
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): SCITON, INC.; 925 commercial street; palo alto CA 94303
• MDR Report Key: 10482270
• MDR Text Key: 205298883
• Report Number: 10482270
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1460 DA