MAUDE Adverse Event Report: Medos International SÃ rl FMS VUE II; Arthroscope

Catalog Number	284004
Medical Device Problem Codes	Increase in Pressure (1491); Improper Flow or Infusion (2954); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgical procedure, during the middle of the surgery, the fluid flow suddenly increased and began splashing from the incision site.Adjustments were made by decreasing and increasing the pressure; however, eventually only a small amount of fluid, at the level of dripping droplets, could be delivered even when pressure was applied.The procedure was completed successfully.There was no surgical delay and no patient harm reported.No further information is available.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.H11.Additional narrative: the complaint device was not returned to depuy synthes, therefore unavailable for a physical evaluation.Given that no lot/serial number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot/serial number becomes available, the mre review will be performed.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.E1: the reporter¿s complete facility address was not provided.

• Brand Name: FMS VUE II
• Common Device Name: Arthroscope
• Manufacturer (Section D): Medos International SÃ rl; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): Medos International SÃ rl; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA ; +1(908)386-3534
• MDR Report Key: 50482891
• Report Number: 1221934-2026-03849
• Device Sequence Number: 10323748
• Product Code: HRX
• UDI-Device Identifier: 10886705027934
• UDI-Public: (01)10886705027934
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup

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: 284004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown