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

Model Number 0010-2400

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/13/2021

Event Type  malfunction  

Event Description

It was reported that the sterile packaging inside the box was opened.A second fiber was used to complete the procedure with no clinical consequences to the patient.

Event Description

It was reported that the sterile packaging inside the box was opened.A second fiber was used to complete the procedure with no clinical consequences to the patient.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes that the reported event of inner sterile packaging unsealed was unable to be confirmed through analysis as the fiber pouch was not returned for analysis.However, a review of the device history record (dhr) confirmed that the pouch sealing process and pouch testing met all material, assembly, and performance specifications.Device technical analysis: the fiber, fiber card, and the product label a cutout piece from outer box were returned for analysis to our post market quality assurance laboratory; however, the fiber pouch was not returned for analysis.Visual and function analysis confirmed that the fiber was unused, and it performed within specifications.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Device history record: the device history record (dhr) confirmed that the pouch sealing process and pouch testing met all material, assembly, and performance specifications.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.

• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12665427
• MDR Text Key: 277397192
• Report Number: 2124215-2021-31775
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 0026380991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• 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