MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL FOOT PEDAL(FMS VUE/NEXTRA); FOOT-SWITCH, ELECTRICAL

Catalog Number 283573

Device Problem Intermittent Continuity (1121)

Patient Problem Not Applicable (3189)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Initial reporter phone number (b)(6).Udi:(b)(4).The serial number is number is unknown.

Event Description

It was reported by the affiliate via email that during a shoulder arthroscopy the foot pedal(fms vue/nextra) was trapped under the table, when the operation table was been set up.The table was unlocked, raised and than moved.It looks like the cable was run over and the pedal flaps were damaged.Also, the handpiece was constantly "on" only disconnecting the foot pedal from the pump console the handpiece will turn off.As per the surgeon the an alternate handpiece was used but the issued remained.An alternate foot pedal from a different pump had to be used to complete the procedure.No patient consequence was reported.However, there was a 2 minutes surgical delayed.

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: correction: d3, g1-g2: the manufacturer name and manufacturer site name were documented as depuy mitek llc us on the initial report.It has been updated as medos international sarl.Additional information: d4: the lot number has been updated as g46ay1855.A manufacturing record evaluation was performed for the finished device lot/serial number g46ay1855, and no non-conformances were identified.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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: investigation summary
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> the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.At this point in time, 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
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> a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.

• Brand Name: FOOT PEDAL(FMS VUE/NEXTRA)
• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle MA 02400 ; SZ 02400
• MDR Report Key: 9312798
• MDR Text Key: 207359416
• Report Number: 1221934-2019-59493
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705017010
• UDI-Public: 10886705017010
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283573
• Device Lot Number: G46AY1855
• Date Manufacturer Received: 01/10/2020
• Patient Sequence Number: 1