MAUDE Adverse Event Report: WISDOM MEDICAL TECHNOLOGY, LLC TWISTER L

Model Number 101220-IC

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

Patient Problem No Consequences Or Impact To Patient (2199)

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 broken tip and ensured that no particles remained in the patient.The representative for the laser was present in the operating suite during this malfunction.There was no harm to the patient.

• Brand Name: TWISTER L
• Type of Device: TWISTER L
• Manufacturer (Section D): WISDOM MEDICAL TECHNOLOGY, LLC; 19 stonehill road; oswego IL 60543
• Manufacturer (Section G): WISDOM MEDICAL TECHNOLGY, LLC; 19 stonehill road; oswego 60543
• Manufacturer Contact: tony jakubowski ; 19 stonehill road; oswego, IL 60543 ; 6308036383
• MDR Report Key: 8366942
• MDR Text Key: 137421872
• Report Number: 3013532143-2019-07001
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/08/2022
• Device Model Number: 101220-IC
• Device Catalogue Number: 101220-IC
• Device Lot Number: DH17007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Distributor Facility Aware Date: 02/25/2019
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1