MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ENDOBEAM HOLMIUM LASER FIBER

Model Number SU0200

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

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2020

Event Type  malfunction  

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 the laser fibers had already been found broken while taking out it from shaft section.

Event Description

It was reported that the laser fibers had already been found broken while taking it out from the shaft section.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.An endobeam holmium laser fiber was returned.The proximal connector end and the distal end were found to be in good condition.The fiber was found to have a compound breakage at the base of the connector.The reported event was confirmed to have a relationship with the device as it contains a compound breakage.The root cause of this issue was unknown, however, a potential root cause for this failure mode could be due to ¿material selection and inappropriate package design.¿ which resulted in excessive stress, and/or bending of the fiber caused it to fracture.The device was not being used at the time of the reported event.It was unknown whether the device had met specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "indications for use: the bard® endobeam¿ holmium laser fibers are indicated for a variety of surgical uses including open, laparoscopic, or endoscopic ablation, incision, excision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation and fragmentation of calculi.The delivery system may be used in surgical specialty procedures for which compatible holmium lasers have received regulatory clearance.Refer to your laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.Contraindications: the devices are contraindicated for treatment of patients for whom endoscopic procedures are not recommended.Refer to the laser system manual for contraindications that may be specific to each surgical specialty.Warnings: improper use of the device or use of a damaged device may result in severe eye or tissue damage, accidental laser exposure to the treatment room personnel or patient which may result in severe burns to the user or patient, and fire in the treatment room.Baskets, guidewires and other ureteroscopic accessories may be damaged by direct contact with the laser treatment beam.Do not bend fiber at sharp angles.If visible light (aiming beam) can be seen leaking from the fiber, fiber failure may result when therapeutic energy is applied as the fiber is deflected beyond the optical limits of total internal reflection.Fiber should not be clamped with forceps or other securing instruments as it may result in fiber damage or breakage.Ensure that all procedure room personnel wear appropriate protective eyewear during the delivery of laser energy.Failure to do so may result in injury.For the single-use laser fiber, do not sterilize any portion of the device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.The reusable laser fibers must be thoroughly cleaned and sterilized before reuse.A tapping noise may indicate fiber misalignment to generator.See fiber output test for additional details and instructions.Precautions: when removing the fiber from its pouch or tray, secure the distal tip to avoid damage or contamination.Do not apply excessive force to the tip of the fiber as breakage may result.Begin lasing at the lowest possible power/energy setting to achieve the desired effect.Use lower power levels and shorter pulses to familiarize yourself with the operation of the bard® endobeam¿ holmium laser fiber.High power/long duration of laser energy while placing the tip in contact with tissue may damage or significantly reduce the life of this product.Direct contact by laser beam may cause damage to guidewires, baskets or other ureteroscopic accessories.If fiber tip is visibly damaged or requires excessive amounts of energy to affect coagulation or vaporization, discontinue use and replace with a new fiber for optimum results.If desired, strip and cleave the fiber as outlined in the ¿instructions for stripping and cleaving¿ and ¿fiber output test¿ sections of this ifu.Do not exceed the recommended power levels when utilizing the bard® endobeam¿ holmium laser fiber.Check the device for completeness once removed from patient.Instructions for use: note: in order to ensure laser energy is effectively delivered through the laser fibers, laser generators must be calibrated and aligned according to the smallest fiber being utilized.This is especially important when utilizing small gauge fibers (200).Improper calibration and/ or improper alignment may result in a weak aiming beam and/or diminished power output.Note: refrain from starting the procedure until a fiber is properly connected and aligned, and laser light is being properly transmitted.Note: it is good practice to ensure that spare fibers are available in the operating room in case of a fiber failure during the clinical procedure.1.Refer to the laser system manual for use, indications and instructions.2.If required for proper system function and operation, the laser system may be calibrated for use with the holmium laser fiber.Please refer to your laser user manual for calibration requirements and parameters.3.Read all fiber labeling completely.Remove the fiber carefully from its package, avoiding any inadvertent contamination or damage.Visually inspect the fiber before use.If any damage is observed such as breaks, kinks or damaged components, do not use the fiber, retain the device for manufacturer notification and use a replacement fiber.4.Remove the protective cap (do not hold the rubber strain relief or the fiber) and attach the connector to the laser system launch port.Make sure the connector is fully engaged according to the system¿s user manual and control panel indicators.The connector only needs to be hand tightened: do not over tighten.Caution: care must be taken to keep the connector clean.Do not touch the exposed fiber surface.5.Turn the laser on.Operate the system¿s controls in accordance with the user manual and at settings appropriate to the procedure.6.Place the holmium laser fiber at the desired position to the treatment site.Position the entire fiber length carefully to avoid inadvertent damage or contamination.Confirm that the aiming beam is visible.7.Depress the laser system¿s footswitch to activate the laser output.Caution: do not pinch or otherwise excessively bend the fiber when lasing.Fiber failure may occur.8.Keep the distal tip of the fiber as clean as possible during use to prevent overheating and damage.If removal is necessary to clean accumulated debris, carefully wipe along the fiber length with a soft gauze and hydrogen peroxide.Caution: do not scrub or use abrasive materials.9.Following the laser procedure, shut the laser system off, as described in your user manual, and remove the fiber assembly from the laser.Immediately replace the protective cap over the connector end of the fiber assembly." h11:section a through f - the information provided by bd 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 bd.

• Brand Name: ENDOBEAM HOLMIUM LASER FIBER
• Type of Device: LASER FIBER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10290084
• MDR Text Key: 199988387
• Report Number: 1018233-2020-04630
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00801741122194
• UDI-Public: (01)00801741122194
• Combination Product (y/n): N
• PMA/PMN Number: K120926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

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: 01/11/2021
• Device Model Number: SU0200
• Device Catalogue Number: SU0200
• Device Lot Number: BMDNLP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1