MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL FMS VUE PUMP-SHAVER BOX DISTENSION UNIT, FLUID, ARTHROSCOPIC

Catalog Number 284004

Device Problems Device Alarm System (1012); Decrease in Pressure (1490); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Not Applicable (3189)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(6). Investigation summary: the device was sent to the service center for evaluation. As per the input check report, pinch valve lever is hard to move, irrigation motor intermittently stops running and error code fc002 is being displayed. The device was repaired, pneumatic circuit checked, and functional test performed. Therefore, the root cause for the reported pressure issue can be attributed to user error. A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. At this point, no corrective action is required, and no further action is warranted. However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. Udi: (b)(4).

Event Description

It was reported by the affiliate via phone that during a 'coiffe' procedure, following issues were occurred with their fms vue pump - shaver box. Affiliated stated that the pump got frozen during use, the irrigation roller pumps were not turning and the pressure fell down to zero quickly. This issue was solved by restarting the pump and the case was completed by using the same device. It was stated that a similar issue was occurred earlier in which the pressure dropped from 90 to 44 and that issue has been solved by restarting the pump. The customer has requested a loaner and is considering a replacement. They are also asking and requesting advise regarding the below: ''related to electrode? related to the foot pedal short circuit ? does the pedal need to be changed?". They also wants explanation about the blinking blue led light and the pressure red alert. Additional information received from the affiliate reported the surgeon was not able to see correctly the surgical site due to the incident. The affiliate also reported there was a 5 minute delay with no patient consequence. The affiliate stated the distributor said surgical intervention of some type was planned but further details could not be provided.

• Brand Name: FMS VUE PUMP-SHAVER BOX
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• 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 ; MA ; 6103142063
• MDR Report Key: 8847955
• MDR Text Key: 153236157
• Report Number: 1221934-2019-57860
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K171237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 284004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2018
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage