MAUDE Adverse Event Report: LUMENIS LTD. XPEEDA DSL FIBER; HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE

Model Number XPEEDA DSL FIBER

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

A search of the complaint database revealed that no other complaints exist for the specified lot.A review of subject device risk files identified the following risk of 'foreign body in the body cavity': (1003791_k : risk #7.1.1) triggered by "side firing fiber's stainless steel cap (tip) is separated from the fiber" has the potential to lead to lacerations (patient injury).In the reported case, the fiber piece was retrieved and a new fiber was used to complete the case with no reported injury or patient complications having been received.The risk has been quantified and found to be negligibly small, and the risk has been characterized and documented as acceptable within full risk assessment.The subject device is expected to be returned to the manufacturer for further investigation; if new information is received with which to determine a cause for reported event, lumenis will file a follow-up mdr.

Event Description

A user facility reported that during a procedure in which a lumenis xpeeda fiber was being utilized , the tip of the fiber broke off in the patient.The tip was retrieved and a new fiber was used to complete the case.No report of patient injury was received, and the event did not cause or contribute to any change in the patient's condition.

• Brand Name: XPEEDA DSL FIBER
• Type of Device: HOLMIUM (HO:YAG) SURGICAL LASERS AND 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
• MDR Report Key: 9731660
• MDR Text Key: 205581377
• Report Number: 3004135191-2020-00014
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140278
• UDI-Public: 07290109140278
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2023
• Device Model Number: XPEEDA DSL FIBER
• Device Catalogue Number: AC-1000729
• Device Lot Number: 08990618
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1