MAUDE Adverse Event Report: LUMENIS, LTD UNKNOWN; LASER FIBER DELIVERY DEVICE

Model Number UNKNOWN

Device Problems Thermal Decomposition of Device (1071); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

Lumenis investigated the reported event by contacting the user facility directly to receive additional information.Despite reasonable attempts by phone (1) and by email (2), the user facility has yet to provide additional information.The subject device has since been returned by the user facility to the distributor who in turn is expected to return the subject device to lumenis for investigation.Until now no product has been received by the distributor.Insufficient information is provided in the initial report to complete an investigation and to determine a possible root cause.Should additional information be provided by the user facility to lumenis with which to determine a cause for reported event, lumenis will file a follow-up mdr.

Event Description

It was reported by a user facility that the tip of a laser fiber broke off inside the scope during a procedure, subsequently damaging the scope.No fiber fragments had fallen into the patient.No patient complications were reported.

Manufacturer Narrative

It was reported by the user facility that this complaint was opened in error and the fiber which broke was not manufactured by lumenis.The facility did not mention who the correct manufacturer is.

Event Description

It was reported by a user facility that the tip of a laser fiber broke off inside the scope during a procedure, subsequently damaging the scope.No fiber fragments had fallen into the patient.No patient complications were reported.It was later reported by the facility that this complaint was opened in error and the fiber which broke was not manufactured by lumenis.The facility did not mention which product was used.

• Brand Name: UNKNOWN
• Type of Device: LASER FIBER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS, LTD; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: alan vaisman ; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692 ; 49599044
• MDR Report Key: 6403530
• MDR Text Key: 69948492
• Report Number: 3004135191-2017-00030
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

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
• Device Operator: Other
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1