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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) SUREFLEX FIBERS; POWERED LASER SURGICAL INSTRUMENT
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AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) SUREFLEX FIBERS; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number S-LLF273TG
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This is for the same event as manufacturer report number 2937094-2018-00060.
 
Event or Problem Description
It was reported that during a procedure, two fibers were broken 2cm from the exit of the operating canal.The method used to complete the procedure was not reported.No additional event information was provided.There was no injury reported.This event is for the second surgical fiber used.
 
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Brand Name
SUREFLEX FIBERS
Common Device Name
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
3070 orchard drive
san jose CA 95134
MDR Report Key7208662
Report Number2937094-2018-00061
Device Sequence Number19090644
Product Code GEX
UDI-Device Identifier00878953004839
UDI-Public00878953004839
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Pharmacist
Type of Report Initial
Report Date (Section B) 12/27/2017
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 Date08/31/2020
Device Model NumberS-LLF273TG
Device Catalogue NumberS-LLF273TG
Device Lot Number736A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/22/2017
Initial Report FDA Received Date01/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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