MAUDE Adverse Event Report: WISDOM MEDICAL TECHNOLOGIES TWISTER L; POWER LASER SURGICAL INSTRUMENT

Catalog Number 101220-1C

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

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

Event Date 01/31/2019

Event Type  malfunction  

Event Description

During a cystoscopy turp, a twister l fiber was used with the evolve laser.The surgeon noted that the fiber tip fragmented and broke off.The surgeon was able to retain the portion of the broken tip and ensured no particles remained in the patient.The representative/vendor for the laser company was present in the operating suite during this malfunction.There was no harm to the patient.Dates of use: (b)(6) 2019.Diagnosis or reason for use: laser tip used for prostate surgery.Is the product compounded? no.Is the product over-the-counter? no.

• Brand Name: TWISTER L
• Type of Device: POWER LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): WISDOM MEDICAL TECHNOLOGIES; oswego IL 60543
• MDR Report Key: 8306585
• MDR Text Key: 135887404
• Report Number: MW5083707
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• 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: 02/01/2019

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: Health Professional
• Device Expiration Date: 08/08/2022
• Device Catalogue Number: 101220-1C
• Device Lot Number: DH17007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2019
• 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: 58 YR
• Patient Weight: 109