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

Model Number	0644-026-01
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, the energy in the fiber fired into the hand of the physician, causing a burn; no information was provided on whether or not treatment was administered for the burn.The procedure was successfully completed without patient complications.
Event or Problem Description
It was reported that during a procedure, the energy in the fiber fired into the hand of the physician, causing a burn; no information was provided on whether or not treatment was administered for the burn.The procedure was successfully completed without patient complications.
Additional Manufacturer Narrative
H6 device codes: defective device, code correction.There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risks associated with implants of these devices as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Additional Manufacturer Narrative
There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risks associated with implants of these devices as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, the energy in the fiber fired into the hand of the physician, causing a burn; no information was provided on whether or not treatment was administered for the burn.The procedure was successfully completed without patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation of device operates differently than expected cannot be confirmed.Regarding the additional information of user experiencing issues with the non-bsc scopes, it is possible that the reported use of an incompatible scope could have damaged the fiber and contributed to the event.The reported adverse event of burn is a known risks associated with use of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, the energy in the fiber fired into the hand of the physician, causing a burn; no information was provided on whether or not treatment was administered for the burn.The procedure was successfully completed without patient complications.Further information obtained indicated that the user is experiencing issues with the scopes (non- bsc) used during procedure.The short-term solution with the scope issues was to insert a slim catheter into the working channel of the scope to prevent the laser rattling around during procedure.However, the working channel appears to be too large in diameter.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma 6,; yokneam AZ 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: 16820568
• Report Number: 2124215-2023-18414
• Device Sequence Number: 6671138
• Product Code: GEX
• UDI-Device Identifier: 07290109140216
• UDI-Public: 07290109140216
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0644-026-01
• Device Catalogue Number: 0644-026-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 09/07/2023; 09/21/2023; 10/31/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 09/11/2023; 10/04/2023; 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown