MAUDE Adverse Event Report: TRIMEDYNE, INC. 20475M-HP OMNITIP SWITCHABLE TIP - 20 DEGREE; LASER FIBER

Model Number 20475M-HP

Device Problems Material Fragmentation (1261); Particulates (1451); Material Separation (1562); Smoking (1585)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2015

Event Type  malfunction  

Event Description

Customer initially reported "laser probe while in knee during arthroscopy, could see black debris and smoke inside knee when it blew.This laser tip had been resterilized x1." at a later date customer reported "laser probe blew while in the knee.Debris removed via grabbers and flushed out with saline via pump." this information is documented as reported to trimedyne, inc.

Manufacturer Narrative

(b)(4).Evaluation, method: device not returned-evaluation based on reporter's narrative.

• Brand Name: 20475M-HP OMNITIP SWITCHABLE TIP - 20 DEGREE
• Type of Device: LASER FIBER
• Manufacturer (Section D): TRIMEDYNE, INC.; 5 holland, building 223; irvine CA 92618 257
• Manufacturer (Section G): TRIMEDYNE, INC.; 5 holland, building 223; irvine CA 92618 257
• Manufacturer Contact: glenn yeik ; 5 holland, building 223; irvine, CA 92618-2579 ; 9499513800
• MDR Report Key: 4866944
• MDR Text Key: 22055582
• Report Number: 1419951-2015-00001
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/24/2015

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: Other
• Device Expiration Date: 05/31/2017
• Device Model Number: 20475M-HP
• Device Catalogue Number: 20475M-HP
• Device Lot Number: 14E041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1