MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ENDOBEAM HOLMIUM LASER FIBER

Model Number	SU0200
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2020
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.
Event or Problem Description
It was reported that the user heard a snapping sound and the device was broken a short time after the laser irradiation.
Event or Problem Description
It was reported that the user heard a snapping sound and the device was broken in a short time after the laser irradiation.
Additional Manufacturer Narrative
The reported event was confirmed, however the cause was unknown.A laser fiber was returned open without its original package.Based on the evaluation the proximal connector and the distal ends were missing.The fiber was about 1 meter shorter than the normal and was burned at both the ends.According to the laser peripherals, a potential root cause for this failure mode could be due to instrumentation falling on the coiled fiber in the package and fractured the fiber.The fiber would potentially proceeded to break when the laser fired the energy through the compromised fiber.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to labeling was not provided by the bd or laser peripherals.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: ENDOBEAM HOLMIUM LASER FIBER
• Common Device Name: LASER FIBER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10382165
• Report Number: 1018233-2020-05068
• Device Sequence Number: 16740710
• Product Code: GEX
• UDI-Device Identifier: 00801741122194
• UDI-Public: (01)00801741122194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 02/24/2022
• Device Model Number: SU0200
• Device Catalogue Number: SU0200
• Device Lot Number: BMENLP04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1