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

Model Number 101220

Device Problem Material Fragmentation (1261)

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

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

A device from the same lot was evaluated and was found to be within the specifications of manufacturing.

Event Description

During a cystoscope and evolve laser turp, the surgeon noted that the fiber optic tip was fragmented.All fragments were retrieved and no harm came the patient.

• Brand Name: TWISTER L
• Type of Device: TWISTER L
• Manufacturer (Section D): WISDOM MEDICAL TECHNOLOGIES, LLC; 19 stonehill road; oswego IL 60543
• Manufacturer (Section G): WISDOM MEDICAL TECHNOLGY, LLC; 19 stonehill road; oswego IL 60543
• Manufacturer Contact: tony jakubowski ; 19 stonehill road; oswego, IL 60543 ; 6308036383
• MDR Report Key: 7370528
• MDR Text Key: 103689811
• Report Number: 3013532143-2018-07002
• 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: 03/22/2018,03/21/2018

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: Physician
• Device Expiration Date: 03/22/2022
• Device Model Number: 101220
• Device Catalogue Number: 101220
• Device Lot Number: DH17016
• 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: 03/22/2018
• Distributor Facility Aware Date: 01/12/2018
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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