MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE, 30°, 5.5X300MM, HI-MAG

Model Number	4K LAPAROSCOPE, 30°, 5.5X300MM, HI-MAG
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On (b)(6) 2023, it was reported by a facility representative via sems that an ar-3352-5530 scope has a blurry image and has spots on the lens.This was discovered during an arthroscopic procedure.The case was completed by using a new scope with no patient harm.

• Brand Name: 4K LAPAROSCOPE, 30°, 5.5X300MM, HI-MAG
• Common Device Name: LAPAROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17336829
• Report Number: 1220246-2023-07189
• Device Sequence Number: 6608260
• Product Code: GCJ
• UDI-Device Identifier: 00888867216761
• UDI-Public: 00888867216761
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K941541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/17/2023

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: 4K LAPAROSCOPE, 30°, 5.5X300MM, HI-MAG
• Device Catalogue Number: AR-3352-5530
• Device Lot Number: 14093953
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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