MAUDE Adverse Event Report: INNOVAQUARTZ LLC PROFLEX; POWERED LASER SURGICAL INSTRUMENT

Model Number LSU273PF

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 10/16/2019

Event Type  malfunction  

Event Description

During a urological procedure a fragment of the holmium laser fiber broke off into the patient's left kidney.The surgeon retrieved the fragment that he could see; bard proflex 273, ref # lsu273pf, lot 14819004.Laser lithotripsy was performed using a holmium laser fiber.The stone was obliterated into small fragments under direct vision.Stone fragments were extracted with a wire basket and sent for stone analysis.A small fragment of the laser fiber was visualized in the calyx and removed with a ureteral biopsy forcep.

• Brand Name: PROFLEX
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): INNOVAQUARTZ LLC; 23030 n 15th ave; phoenix AZ 85027
• MDR Report Key: 9271334
• MDR Text Key: 164835960
• Report Number: 9271334
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSU273PF
• Device Catalogue Number: LSU273PF
• Device Lot Number: 14819004
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29930 DA