MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INFLOW TUBING FMS VUE 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number 284508

Device Problem Overfill (2404)

Patient Problem Not Applicable (3189)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4). Udi: (b)(4).

Event Description

It was reported by the affiliate that during an arthroscopic rotator cuff repair when the remote control (fms vue/nextra) was connected to a unit preoperatively, it beeped and the error code fc014 was shown in the display, when the remote control was disconnected it stopped beeping. Then again it was reconnected to the unit and the beeping recurred. The remote control (fms vue/nextra) was not used in the procedure. The fluid volume in the chamber of the inflow tubing fms vue 24pk kept increasing up to the maximum level, then the pumping stopped working. The clamp connecting the irrigated fluid was closed, but the fluid did not decreased, they had to use a second intermediary tubeset 24pk but the same issue occurred an hour later and the water did not flow, even thought the error code was not shown on the display, the unit beeped and than the irrigation stopped working. They kept using the unit with a replacing arthrex pump, the shaver without the outflow tubing, and a replacing suction tubing. There was no patient consequence, however there was a surgical delay for less than 30 minutes. No additional information was provided.

• Brand Name: INFLOW TUBING FMS VUE 24PK
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9668212
• MDR Text Key: 203537279
• Report Number: 1221934-2020-00489
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/30/2021
• Device Model Number: 284508
• Device Catalogue Number: 284508
• Device Lot Number: 5986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial