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

Model Number 284002

Device Problem Intermittent Continuity (1121)

Patient Problem Not Applicable (3189)

Event Date 11/11/2019

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. Initial reporter phone number: (b)(6). Investigation summary: the device was received and evaluated at the service center. The failures reported by the customer were unable to be confirmed upon evaluation. However, it was found that the cpu board was defective and that the device restarts when the shaver is activated. The device had initialization failure and there was alarm during operation. The defective cpu board was replaced, the device cleaned, newly calibrated, tested and found to be fully functional. The defective cpu board can be held responsible for the identified failures during evaluation of the device. However, since the reported conditions were not confirmed,the root cause for the reported failures cannot be determined. The service history has been reviewed in lieu of the device history record for this device since it was previously serviced. The device was last serviced on (b)(6) 2019 and passed all functional testing before being returned to the customer. At this point in time, no corrective action is required, and no further action is warranted. Depuy 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 affiliate via phone that during a shoulder repair, fms vue fluid management system handpieces were getting too hot, the finger switch did not responded the way it should, 1 shaver was not responding at all, and the pressure was not held in some occasion. Another handpiece and fms pump were used to complete the surgery. There was surgical delay.

• Brand Name: FMS VUE PUMP
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9650175
• MDR Text Key: 191538683
• Report Number: 1221934-2020-00377
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 284002
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage