MAUDE Adverse Event Report: QUANTA SYSTEM SPA QUANTA HOLMIUM LASER FIBER SU; QUANTA LASER FIBER

Catalog Number OAF002011

Device Problem Material Fragmentation (1261)

Patient Problem Burn(s) (1757)

Event Date 12/21/2022

Event Type  Injury  

Event Description

It was reported that the doctor was using an aptra scope and had a 200-laser fiber through the working channel in the lower pole of the kidney.It was stated that the doctor was moving the tip of the scope, while doing so, was also bending the fiber, causing the fiber to break in half by the accessory port of the aptra scope.The fiber broke and burnt the doctor¿s thumb and pointer finger.No medical intervention was reported.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that doctor was using aptra scope and had a 200-laser fiber through the working channel in the lower pole of the kidney.Stated that the doctor was moving the tip of the scope, while doing so, was also bending the fiber causing the fiber to break in half by the accessory port of the aptra scope.The fiber broke and burnt the doctor¿s thumb and pointer finger.Per additional information received via form with sample returned on 18jan2023, it was reported that the doctor was using flexible ureteroscope and fiber.They bent fiber causing burn to their left thumb and index finger.

Event Description

It was reported that doctor was using aptra scope and had a 200-laser fiber through the working channel in the lower pole of the kidney.Stated that the doctor was moving the tip of the scope, while doing so, was also bending the fiber causing the fiber to break in half by the accessory port of the aptra scope.The fiber broke and burnt the doctor¿s thumb and pointer finger.Per additional information received via form with sample returned on 18jan2023, it was reported that the doctor was using flexible ureteroscope and fiber.They bent fiber causing burn to their left thumb and index finger.

Manufacturer Narrative

The reported event was confirmed and the cause was unknown.The quanta laser fiber was returned.A portion of the fiber was noted to be broken off.Though a specific cause cannot be determined, a potential root cause for this event could be incorrect handling.The device was used for treatment purposes.It is unknown if the device had met all relevant specifications.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warning: this product shall be used by trained and qualified users only.Perform a visual inspection after the fiber has been removed from the packaging.Ensure the distal end it intact and the sma plug is clean.Do not use the fiber with a damaged distal end or sma plug.Before and after removing the laser fiber from its packaging, check the fiber for visible signs of damage, in particular, breakage.If any damage is found, do not use the product! the minimum bending radius of the laser fiber must be maintained at all times throughout the entire time of use.Always prevent the distal end of the fiber from coming into contact with reflecting surfaces of other instruments or products used in order to prevent any uncontrolled leakage radiation or damage to the fiber or tissue." correction: g.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the actual/suspected device was inspected.

• Brand Name: QUANTA HOLMIUM LASER FIBER SU
• Type of Device: QUANTA LASER FIBER
• Manufacturer (Section D): QUANTA SYSTEM SPA; via acquedotto, 109; samarate va 21017 ; IT 21017
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16148416
• MDR Text Key: 308444581
• Report Number: 1018233-2022-10340
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OAF002011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2022
• Event Location: Other
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other