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

Model Number	GA-0006800
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a puddle of about the size of a cup was noted under the console after the procedure.There was no dripping or leak observed.The physician then touched the bis sensor of the brain monitoring system (a sticker-like electrode on the forehead), causing a 1mm blister on his left ring finger.No patient complications were reported.
Event or Problem Description
It was reported that a puddle of about the size of a cup was noted under the console after the procedure.There was no dripping/leak observed.The physician then touched the bis sensor of the brain monitoring system (a sticker-like electrode on the forehead), causing a 1mm blister on the left ring finger.No patient complications were reported.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this unit was serviced at the facility by a field service engineer (fse).The fse identified a possible internal leakage at the chiller, that could have contributed to the puddle under the console.Based on this information, the reported event is confirmed.The fse found no issues with the console that could have led to the reported blister to physician left finger.The labelling review did not reveal any evidence of device off-label use or failure to follow instructions.The instruction for use (ifu) instructs that because the lumenis pulse 120h holmium laser system contains highvoltage components, there is a danger of severe shock if its covers are taken off by persons other than trained personnel.To avoid injury, do not operate the unit before ensuring that all covers are properly closed, except when performing repairs that necessitate otherwise.Do not attempt to remove or to disassemble any panels or covers without first disconnecting the power cord of the system.Based on the information available, and console analysis results, an evaluation conclusion code of cause traced to component failure was assigned for the identified leakage found in the chiller component.

• Brand Name: PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15349840
• Report Number: 2124215-2022-34001
• Device Sequence Number: 14760038
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA-0006800
• Device Catalogue Number: GA-0006800
• Device Lot Number: 0000000072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown