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

Model Number	0644-019-01
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during unpacking, a foreign body dropped out from the new fiber when it was opened from the packaging.The procedure was completed using another device without patient complications.
Event or Problem Description
It was reported that during unpacking, a foreign body dropped out from the new fiber when it was opened from the packaging.The foreign body was a piece of plastic from the fiber.The procedure was completed using another device without patient complications.
Event or Problem Description
It was reported that during unpacking, a foreign body dropped out from the new fiber when it was opened from the packaging.The foreign body was a piece of plastic from the fiber.The procedure was completed using another device without patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber confirmed the reported foreign matter as analysis identified that the radio frequency identification (rfid) chip component was separated from the fiber connector.It was observed that the fiber tip was slightly degraded.During functional testing of the fiber, the connector had no abnormality.The aiming beam was bright and round.There was a message on the console that displayed error 65.The rfid chip is a component part of the fiber.The chip was returned, separated from the fiber connector.The chip is placed into the connector with glue and possibly gets handling or sterilization.After usage, it is likely the chip became loose and fell out, and that the identified detached chip is the foreign body that was reported.It was mentioned that the fiber was new, however the observed tip degradation indicates the fiber had some usage.It is likely that the event occurred after the device was packaged during manufacturing but prior to use of the device by the complainant.According to the instructions for use (ifu), the ifu states: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement.Ensure the fiber is properly handled so that it is not damaged by being stepped on, pulled, left lying in a vulnerable position, kinked or tightly coiled.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma 6,; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21971950
• Report Number: 2124215-2025-28761
• Device Sequence Number: 18230438
• Product Code: GEX
• UDI-Device Identifier: 07290109145587
• UDI-Public: (01)07290109145587(17)270801(10)2160922
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2025

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 Model Number: 0644-019-01
• Device Catalogue Number: 0644-019-01
• Device Lot Number: 02160922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 07/21/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/10/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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