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).Device was used for treatment, not diagnosis.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information: investigation summary
=
> the complaint device was received and evaluated.Visual observation reveals that device was received without any physical damage.Some fluid was observed inside the tube.Functional testing of the inflow tube cannot be performed as the pump was not received at cq.Thus, the reported complaint cannot be confirmed.Defective pump or display might have contributed to the reported complaint condition.An mre was reviewed, no non-conformances were identified for the reported part 284508- lot 5986 number combination.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.Device history lot
=
> a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.

• 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
• MDR Report Key: 9683300
• MDR Text Key: 206584597
• Report Number: 1221934-2020-00509
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705023066
• UDI-Public: 10886705023066
• Combination Product (y/n): N
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/04/2020
• Patient Sequence Number: 1