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

Model Number	4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device has not yet been evaluated.The root cause of the event could not be determined from the information available and without device evaluation.When the device evaluation becomes available, a follow-up report will be submitted.
Event or Problem Description
On 10/16/2023 it was reported by a sales representative, via (b)(4), that an ar-3352-5531 4k laparoscope rod lens seemed to be loose due to an internal failure.It will come in and out of focus.It was stated that the device was not dropped.This was discovered during an arthroscopy procedure on 10/16/2023, with no patient harm.
Additional Manufacturer Narrative
The most likely cause of the failure is handling use error.¿ carry out a visual inspection and function check prior to each use.¿ only use endoscopes which are in perfect condition.The cause remains misuse.

• Brand Name: 4K LAPAROSCOPE,30¿,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: emily shafer ; 8009337001
• MDR Report Key: 18151979
• Report Number: 1220246-2023-08771
• Device Sequence Number: 17795370
• Product Code: GCJ
• UDI-Device Identifier: 00888867346628
• UDI-Public: 00888867346628
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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 Model Number: 4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
• Device Catalogue Number: AR-3352-5531
• Device Lot Number: 14423351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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