MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PROFLEX LUMENIS 200 SINGLEUSE; LASER FIBERS

Catalog Number	LSU200PF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that 4cm of the fiber broke off, while inside the patient.The complainant alleged that the fiber was lodged between pieces of the stone, and was completely removed.The fiber was in use for five minutes before the break occurred.There were no procedure delays, no additional procedures performed, and no patient injury was reported.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error, as bard medical does not have regulatory reporting responsibility for the innovaquartz laser fibers.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that 4cm of the fiber broke off, while inside the patient.The complainant alleged that the fiber was lodged between pieces of the stone, and was completely removed.The fiber was in use for five minutes before the break occurred.There were no procedure delays, no additional procedures performed, and no patient injury was reported.

• Brand Name: PROFLEX LUMENIS 200 SINGLEUSE
• Common Device Name: LASER FIBERS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6613059
• Report Number: 1018233-2017-02914
• Device Sequence Number: 10952751
• Product Code: GEX
• UDI-Device Identifier: 00816959020682
• UDI-Public: (01)00816959020682(17)200310(10)02617005
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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 Date: 03/10/2020
• Device Catalogue Number: LSU200PF
• Device Lot Number: 02617005
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1