MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE,0¿,5.5X300MM, HI-MAG, NIR

Model Number	4K LAPAROSCOPE,0¿,5.5X300MM, HI-MAG, NIR
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 06/18/2024 it was reported by a facility representative via sems(b)(4) that two (qty.2) ar-3352-5501 scopes are providing cloudy images.Case/patient involvement not indicated.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-3352-5501 serial/batch number (b)(6) was received for evaluation.Visual evaluation under a magnifier revealed that the perimeter of the distal end was nicked.Additionally, the lens had damage and debris on it.Functional testing could not be performed due to the lack of testing equipment.However, due to the various signs of external damage, it can be deduced that the device did not function as required as stated in the complaint allegation.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.Dfu-0399-eo revision 1 offers suggestions on maintaining the integrity of the glass: clean/disinfect and sterilize the endoscope and endoscopic medical instruments prior to initial use, as well as after each subsequent use.If not cleaned properly contaminants on the irradiation surfaces of the illumination fibers figure 1 [5] can burn-in during use, which impacts image quality.Ensure that the proximal end of the endoscope figure 1 [4] is dry, to prevent the endoscope from fogging up during the examination/procedure.Ensure that no parts are missing or loose.Ensure that there are no residual cleaning agents or disinfectants on the endoscope and endoscopic medical instruments.Inspect the entire endoscope, particularly the sheath figure 1 [2], as well as endoscopic medical instruments for contaminants and damage of any type, such as dents, scratches, cracks, bending, and sharp edges.Inspect the distal end figure 1 [1], proximal end figure 1 [4] and irradiation surface of the illumination fibers figure 1 [5] for any contaminants and scratches.Make contaminants and scratches visible using light reflexes by holding the endoscope with the connection for the illumination fiber against the light and inspect whether the illumination fibers illuminate evenly at the distal end figure 1 [1].Check image quality: the image should not be blurry, clouded, or dark.If deposits are detected when checking the image quality, they can be removed with the polishing paste.

• Brand Name: 4K LAPAROSCOPE,0¿,5.5X300MM, HI-MAG, NIR
• 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: jared engle ; 8009337001
• MDR Report Key: 19718901
• Report Number: 1220246-2024-06690
• Device Sequence Number: 15462160
• Product Code: GCJ
• UDI-Device Identifier: 00888867346611
• UDI-Public: 00888867346611
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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,0¿,5.5X300MM, HI-MAG, NIR
• Device Catalogue Number: AR-3352-5501
• Device Lot Number: 15147860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown