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

Model Number	0010-2092
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in a photoselective vaporization of the prostate (pvp) procedure, the beam was altered and not inclined from the beginning of the procedure.Another fiber was used to complete the procedure.There was no impact on the patient.
Event or Problem Description
It was reported that in a photoselective vaporization of the prostate (pvp) procedure, the beam was altered and not inclined from the beginning of the procedure.Another fiber was used to complete the procedure.There was no impact on the patient.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Visual analysis found the fiber tip to be in good condition.The glass cap did not exhibit any signs of devitrification or detritus.There was no damage observed to the tip.The fiber was functionally tested with helium-neon (hene) laser fixture.The testing conducted confirmed the aim beam to be was present at the output window, as intended.There were no signs of a fiber body break along its length.The connector cone, segments, and tabs appear in good condition and secured.The control knob is attached and aligned with fiber and can rotate the fiber.Based on analysis results there were no fiber damages observed that could have caused and contributed to the reported event; therefore, it cannot be confirmed.A conclusion code of no problem detected was assigned to this investigation.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

• Brand Name: GREENLIGHT HPS EA FIBER OPTIC
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11164726
• Report Number: 2937094-2021-00009
• Device Sequence Number: 11664561
• Product Code: GEX
• UDI-Device Identifier: 00878953005522
• UDI-Public: 00878953005522
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2022
• Device Model Number: 0010-2092
• Device Catalogue Number: 0010-2092
• Device Lot Number: 0025134926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1