MAUDE Adverse Event Report: DEPUY SPINE INC TELIGEN VUE CAMERA; ARTHROSCOPE

Catalog Number	286006061S
Medical Device Problem Codes	Poor Quality Image (1408); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the image looked like a kaleidoscope when the camera was plugged in.They replaced the camera, but the image remained the same.They checked all the connections and changed the image settings back to default but the image remained unusable.They transitioned to x-ray to complete the surgery.The issue was observed during surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: h3, h6: a review of the receiving inspection (ri) for teligen vue camera, was conducted identifying that lot number 5744933 released in one batch.Batch1: released on september 26, 2024 with no discrepancies supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.An analysis of the product could not be performed since a physical sample was not received for evaluation.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition; therefore, it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: TELIGEN VUE CAMERA
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SCOUTCAM
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24393548
• Report Number: 1526439-2026-00188
• Device Sequence Number: 16074881
• Product Code: HRX
• UDI-Device Identifier: 10705034604510
• UDI-Public: (01)10705034604510(17)270630(10)5744933
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K213978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 286006061S
• Device Lot Number: 5744933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TELIGEN CART ASSEMBLED; TELIGEN HD CCS
• Patient Sex: Unknown