MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENLIGHT MOXY FIBER OPTIC; POWERED LASER SURGICAL INSTRUMENT

Model Number 0010-2400

Device Problems Loss of or Failure to Bond (1068); Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2023

Event Type  malfunction  

Manufacturer Narrative

With the available information, boston scientific concludes that the reported fiber tip rotating was confirmed.Thorough review of the media available, showed what appeared to be a detachment of the glass cap.In addition, the fiber tip was found burnt, indicative of tissue contact.The detachment/missing of the glass/cap is likely to cause the fiber to rotate within metal cap.Likely giving the user the impression that the metal cap is rotating.Review of the device history record confirmed that the fiber met specification prior to release.Based on analysis results, the interaction between the user and device, caused or contributed to the observed fiber damage and reported event.The observed condition of the fiber is consistent with fibers that experienced tissue adhesion, constant heavy tissue contact, and/or a decrease in the saline cooling flow, which leads to elevated temperature near the laser beam output window.Most likely contributing to overheating of the fiber tip leading to diminishing vaporization efficiency, glass cap rotation and subsequently detachment of the glass cap.The ifu instruct the user to: increased irrigation flow by means of a saline pressure bag (set to 250 mmhg to 300 mmhg) will further increase liquid cooling effect and may reduce fiber tip damage.

Event Description

It was reported that during a photo selective vaporization of the prostate for benign prostatic hyperplasia, the fiber stopped working and the beam intensity diminished.In addition, it was noted that the fiber cap was loose and rotating.The procedure was completed with another fiber without patient complications.Analysis of the media provided by the customer was analyzed and identified that glass cap was detached, and the fiber tip was burnt.Good faith effort initiated indicated that the glass cap did not detach inside the patient's body; therefore, there was no removal of the fragment required.It was further clarified that the glass cap detached after removal of the fiber from the patient's body.

Manufacturer Narrative

With the available information, boston scientific concludes that the reported fiber tip rotating was confirmed.Thorough review of the media available and the visual inspection of the returned fiber, confirmed the detachment of the glass cap.In addition, the fiber tip was found burnt, indicative of tissue contact.The detachment/missing of the glass/cap is likely to cause the fiber to rotate within metal cap.Likely giving the user the impression that the metal cap is rotating.Review of the device history record confirmed that the fiber met specification prior to release.Based on analysis results, the interaction between the user and device, caused or contributed to the observed fiber damage and reported event.The observed condition of the fiber is consistent with fibers that experienced tissue adhesion, constant heavy tissue contact, and/or a decrease in the saline cooling flow, which leads to elevated temperature near the laser beam output window.Most likely contributing to overheating of the fiber tip leading to diminishing vaporization efficiency, glass cap rotation and subsequently detachment of the glass cap.The ifu instruct the user to: increased irrigation flow by means of a saline pressure bag (set to 250 mmhg to 300 mmhg) will further increase liquid cooling effect and may reduce fiber tip damage.

Event Description

It was reported that during a photo selective vaporization of the prostate for benign prostatic hyperplasia, the fiber stopped working and the beam intensity diminished.In addition, it was noted that the fiber cap was loose and rotating.The procedure was completed with another fiber without patient complications.Analysis of the media provided by the customer was analyzed and identified that glass cap was detached, and the fiber tip was burnt.Good faith effort initiated indicated that the glass cap did not detach inside the patient's body; therefore, there was no removal of the fragment required.It was further clarified that the glass cap detached after removal of the fiber from the patient's body.

• Brand Name: GREENLIGHT MOXY FIBER OPTIC
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18641230
• MDR Text Key: 334647115
• Report Number: 2124215-2024-05755
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K120870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 0031089648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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 Age: 84 YR
• Patient Sex: Male