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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENLIGHT MOXY FIBER OPTIC; POWERED LASER SURGICAL INSTRUMENT
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BOSTON SCIENTIFIC CORPORATION GREENLIGHT MOXY FIBER OPTIC; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number 0010-2400
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2020
Event Type  malfunction  
Manufacturer Narrative
The exact date of when the event occurred is unknown.
 
Event Description
It was reported that during preparation of a photoselective vaporization of the prostate procedure, with patient under anesthesia, the fiber package opened - not sterile was discovered.Another fiber was chosen to complete the procedure with no clinical consequences to the patient.
 
Event Description
It was reported that during preparation of a photoselective vaporization of the prostate procedure, with patient under anesthesia, the fiber package opened - not sterile was discovered.Another fiber was chosen to complete the procedure with no clinical consequences to the patient.
 
Manufacturer Narrative
The exact date of when the event occurred is unknown.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the returned device identified that the pouch seal was torn along the top.The tear was 5 inches wide.The fiber showed no signs of usuage.Based on the investigation results, it was not possible to determine the most probable cause for the reported event.Therefore; an evaluation conclusion code of cause not established was assigned.
 
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Brand Name
GREENLIGHT MOXY FIBER OPTIC
Type of Device
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
150 baytech drive
san jose CA 95134
MDR Report Key9948719
MDR Text Key187228927
Report Number2937094-2020-00381
Device Sequence Number1
Product Code GEX
UDI-Device Identifier00878953005515
UDI-Public00878953005515
Combination Product (y/n)N
PMA/PMN Number
K120870
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/05/2021
Device Model Number0010-2400
Device Catalogue Number0010-2400
Device Lot Number0023904091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2020
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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