MAUDE Adverse Event Report: WISDOM MEDICAL TECHNOLOGY TWISTER L; LASER

Model Number 101220

Device Problems Material Fragmentation (1261); Material Twisted/Bent (2981)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

During a cystoscopy and evolve laser turp the surgeon noted that 2 twisted l fibers fragmented from the laser.The laser is a loaner device from uhs surgical services and a representative was present during use of the laser.All fragments were retrieved from the patient, no harm to the patient.

• Brand Name: TWISTER L
• Type of Device: LASER
• Manufacturer (Section D): WISDOM MEDICAL TECHNOLOGY; oswego IL 60543
• MDR Report Key: 7133897
• MDR Text Key: 95506823
• Report Number: MW5074121
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101220
• Device Lot Number: DH17016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 87