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

Model Number 0644-020-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

It was reported that a fiber was returned to boston scientific without customer information and device performance allegation.Analysis of the returned fiber identified that the fiber connector was detached.No further information is available.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory this returned fiber was thoroughly analyzed.Visual analysis noted that the fiber connector was detached and not returned.The fiber was kinked and burn marks were visible near the proximal end of the fiber body.The fiber tip was in good condition.Functional testing could not be conducted due to the missing fiber connector.Review of the device history record confirmed that the device met specification prior to release.The identified kink and burn marks located on the fiber body indicate that fiber was used and may have caused or contributed to the reason for device return.

• Brand Name: SLIMLINE SIS EZ
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; 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: 18991456
• MDR Text Key: 339103067
• Report Number: 2124215-2024-17580
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 17290109145669
• UDI-Public: 17290109145669
• Combination Product (y/n): N
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0644-020-01
• Device Catalogue Number: 0644-020-01
• Device Lot Number: 0013120223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1