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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  malfunction  

Event Description

It was reported that during preparation for a photoselective vaporization of the prostate the inside package was opened inside of box.The procedure was continued with a different device without patient complications.

Manufacturer Narrative

The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The product was returned and upon receipt at our post market quality assurance laboratory, this product was thoroughly analyzed.Visual analysis of the returned fiber identified that the fiber arrived in a box that was bent and taped.The pouch that contained the fiber was sealed but there was a large hole on it and the label had been torn.The reported event is confirmed based on the condition of the returned product.A manufacturing steps and inspections investigation were completed and found that there is minimal risk of pouch tears as there is no contact with sharp surfaces.In addition, the investigation confirmed that there are no similar events for the reported lot.Further investigation was able to replicate similar damage to the pouch when opening a box with a sharp instrument.Evidence of the torn label demonstrates that the pouch damage occurred after the label was applied, suggesting user handling.Based on the information available and analysis results, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.

Event Description

It was reported that during preparation for a photoselective vaporization of the prostate the inside package was opened inside of box.The procedure was continued with a different device without patient complications.

• 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
• MDR Report Key: 11136001
• MDR Text Key: 226062468
• Report Number: 2937094-2020-01153
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• PMA/PMN Number: K120870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 0025751804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1