MAUDE Adverse Event Report: OPTICAL INTEGRITY, INC. SMARTSCOPE; POWERED LASER SURGICAL INSTRUMENT

Model Number	11797
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a urology procedure the fiber broke that resulted in a burn to the physician's glove.The fiber "snapped in half" and "burned the physician's glove." it could not be verified how the fiber broke or if the burn was through the glove and caused injury.
Additional Manufacturer Narrative
The returned device was thoroughly analyzed.Visual analysis noted that the fiber was returned in two pieces, and inspection of the fiber indicates a mechanical break at 2140 mm from the proximal end of the fiber.The fiber break appears to be related to the handling of the device.A review of the manufacturing records for this lot shows now ncmrs associated with the lot.Review of the complaint records shows no other complaints for this lot.Based on the information available, a conclusion of known inherent risk of device was assigned to this investigation.

• Brand Name: SMARTSCOPE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): OPTICAL INTEGRITY, INC.; 19408 panama city beach pkwy; panama city beach FL 32413
• Manufacturer (Section G): OPTICAL INTEGRITY, INC; 19408 panama city beach pkwy; panama city beach FL 32413
• Manufacturer Contact: joe brown ; 19408 panama city beach pkwy; panama city beach, FL 32413 ; 8502335512
• MDR Report Key: 19519081
• Report Number: 3003708273-2024-00001
• Device Sequence Number: 6081435
• Product Code: GEX
• UDI-Device Identifier: 00810077630648
• UDI-Public: (01)00810077630648
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K022338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 08/31/2026
• Device Model Number: 11797
• Device Catalogue Number: 11797
• Device Lot Number: M21797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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: Male