MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL FMS VUE II; ARTHROSCOPE

Catalog Number	284004
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair procedure, approximately 5 minutes after the start of the surgery, a water leak was discovered from the fms inflow section.Upon removing the inflow tube cover, a crack was found in the inflow tubing fms device.The irrigation water was stopped, the inflow tube was removed and replaced with a new one.The surrounding wet areas were wiped with gauze to remove moisture, the tube was set up according to the procedure, and the run button was pressed again.Water began to flow, but the low pressure indicator flashed on the fms vue ii pump-shaver box device without detecting pressure.The tube was reattached, and the joints of each tube and the fms connection points were checked.The power was turned off the fms, the tubing was replaced again with a new one, set up according to the procedure, and reattached.It then operated normally.The initial fms setup was performed by the circulating nurse before entering the room, and it was confirmed that there was no damage to the tube.There was no surgical delay and no harm to the patient.No further information is available.This is report 3 of 3 for (b)(4).
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 actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once the investigation has been completed, a follow-up report will be submitted accordingly.E1: the reporter¿s complete facility address was not provided.
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: d9: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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 02767 ; 9083863534
• MDR Report Key: 24904677
• Report Number: 1221934-2026-01533
• Device Sequence Number: 9874045
• Product Code: HRX
• UDI-Device Identifier: 10886705027934
• UDI-Public: (01)10886705027934
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 05/05/2026; 05/05/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/01/2026; 05/05/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2018
• 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