MAUDE Adverse Event Report: TRIMEDYNE MULTI-USE HAND PIECE WITH FIBER AND SMA CONNECTRO, 20 DEGREE ANGLE SWITCH

Model Number 20471M-HP

Device Problems Material Fragmentation (1261); Noise, Audible (3273)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

No injury.During l knee arthroscopy, holmium laser with reprocessed tip was in the knee and laser activated popping noise and flash was observed via video screen.Small piece of the laster tip observed in the knee using video.Several unsuccessful attempts were made to retrieve the piece.Unable to retrieve with irrigation.Brand new laser tip used without complications to finish the case.(b)(6).

• Brand Name: MULTI-USE HAND PIECE WITH FIBER AND SMA CONNECTRO, 20 DEGREE ANGLE SWITCH
• Type of Device: MULTI-USE HAND PIECE WITH FIBER AND SMA CONNECTRO, 20 DEGREE ANGLE SWITCH
• Manufacturer (Section D): TRIMEDYNE; 5 holland, building 223; irving CA 92618
• MDR Report Key: 4300525
• MDR Text Key: 5084320
• Report Number: MW5039386
• Device Sequence Number: 1
• Product Code: GEX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20471M-HP
• Device Lot Number: 14E030
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 46 YR