MAUDE Adverse Event Report: LUMENIS LTD SLIMLINE; POWERED LASER SURGICAL INSTRUMENT

Model Number	0624-149-55
Medical Device Problem Codes	Break (1069); Smoking (1585); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during preparation for a cervical conization procedure, this fiber was left on a cloth that had been placed on the patient.The console screen status remained in ready mode while the laser fiber was outside the patient.The cloth suddenly caught fire; the fire was quickly extinguished and there has no harm to the patient or medical staff.The procedure was completed with the same fiber.It is believed that the system was mistakenly activated, leading to the fire.Additional information was received indicating that the handpiece showed burn marks, indicating that the laser had been fired inside the handpiece.No patient complications were reported.
Additional Manufacturer Narrative
H6 device code: change to reflect break.
Event or Problem Description
It was reported that, during preparation for a cervical conization procedure, this fiber was left on a cloth that had been placed on the patient.The console screen status remained in ready mode while the laser fiber was outside the patient.The cloth suddenly caught fire; the fire was quickly extinguished and there was no harm to the patient or medical staff.The procedure was completed with the same fiber.It is believed that the system was mistakenly activated, leading to the fire.Additional information was received indicating that the handpiece showed burn marks, indicating that the laser had been fired inside the handpiece.This is indicative of a fiber break.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this fiber underwent visual analysis.The returned fiber was in two pieces with the fiber body broken between the connector and the tip.The tip and distal end of the fiber body exhibited evidence of burning.Visual analysis confirmed the reported clinical observation.
Event or Problem Description
It was reported that, during preparation for a cervical conization procedure, this fiber was left on a cloth that had been placed on the patient.The console screen status remained in ready mode while the laser fiber was outside the patient.The cloth suddenly caught fire; the fire was quickly extinguished and there has no harm to the patient or medical staff.The procedure was completed with the same fiber.It is believed that the system was mistakenly activated, leading to the fire.Additional information was received indicating that the handpiece showed burn marks, indicating that the laser had been fired inside the handpiece.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this fiber underwent visual analysis.The returned fiber was in two pieces with the fiber body broken between the connector and the tip.The tip and distal end of the fiber body exhibited evidence of burning.Visual analysis confirmed the reported clinical observation.
Event or Problem Description
It was reported that, during preparation for a cervical conization procedure, this fiber was left on a cloth that had been placed on the patient.The console screen status remained in ready mode while the laser fiber was outside the patient.The cloth suddenly caught fire; the fire was quickly extinguished and there has no harm to the patient or medical staff.The procedure was completed with the same fiber.It is believed that the system was mistakenly activated, leading to the fire.Additional information was received indicating that the handpiece showed burn marks, indicating that the laser had been fired inside the handpiece.No patient complications were reported.

• Brand Name: SLIMLINE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam AZ 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; hakidm 6; phoenix AZ 85023
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15285739
• Report Number: 2124215-2022-31887
• Device Sequence Number: 7166466
• Product Code: GEX
• UDI-Device Identifier: 07290109140025
• UDI-Public: 07290109140025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/27/2023

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: 05/26/2023
• Device Model Number: 0624-149-55
• Device Catalogue Number: 0624-149-55
• Device Lot Number: 0010420618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 10/19/2022; 09/21/2023
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/22/2022; 10/27/2022; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown