MAUDE Adverse Event Report: LUMENIS LTD. LUMENIS PULSE 100H; HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE

Model Number LUMENIS PULSE 100H

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the subject device dhr confirmed that the subject device was manufactured and tested according to relevant procedures, tested before release, and shipped according to manufacturer's specifications.The system was manufactured on 24-feb-2019 and installed at the customer's site on (b)(6) 2019.A lumenis service engineer visited the site three (3) days after the reported event and examined the laser system.Upon troubleshooting, the engineer found shutter securing nuts backed off completely from shutter bolts.Secured shutter assembly nuts, applied lock-tight to ensure nuts do not back off from bolts.Verified shutter operation and after reconfirming it's operation, the engineer returned the system to the facility in working order.A review of historical product complaints shows that the same malfunction of shutter failure has not led to serious injury in the past.A review of system risk files (b)(4) revealed risk #2.3.2; hw failure" which have the potential to lead to prolonged procedure.The risk has been quantified and found to be remote, and the risk likelihood has been characterized and documented as acceptable within full risk assessment.Although the device malfunction did not cause or contribute to any change in the patient's condition, it is uncertain if the user facility had to use the alternate device as intervention to prevent permanent damage.In an abundance of caution, lumenis is reporting this malfunction.A review of service records reviled that the shutter was replaced on 8-dec-2020.It is likely that the nuts were not tightened enough by the service engineer after replacing the shutter.As part of lumenis' commitment to continuous improvement, further investigation is ongoing in a pi for (b)(4) for a similar event.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (b)(4) and per post marketing surveillance procedure (b)(4).

Event Description

A user facility reported that during a holep procedure in which a lumenis pulse 100 was being utilized the system suddenly "stopped working".Unable to continue with the system, an alternate device was brought in to complete the procedure.The delay was approximately 90 minutes and the procedure completed without incident or complication.No report of patient complications was received, and no report was received alleging the device malfunction caused or contributed to any change in the patient's condition.

• Brand Name: LUMENIS PULSE 100H
• Type of Device: HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 12672008
• MDR Text Key: 278223299
• Report Number: 3004135191-2021-00068
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: 07290109140520
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUMENIS PULSE 100H
• Device Catalogue Number: GA-1008944
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1