MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4176 FOOT PEDAL BOARD 4WAY; FOOT-SWITCH, ELECTRICAL

Catalog Number	284176
Medical Device Problem Codes	Intermittent Continuity (1121); Increase in Pressure (1491)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate via service request that the foot ped board 4way needs service as it is having bad contact when it was wet.It was mentioned that when aspiration pedal is pressed the pressure goes up to 120 mmhg.No other information provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Additional 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.Additional narrative: investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had a bad contact when it was wet was confirmed.However, that of the excessive pressure with the device was unable to be confirmed.It was found that the rs232 plug was defective during analysis.The plug was replaced and the device was tested and found to be working according to specifications.The defective valve would have caused the customer to experience the reported issue of the poor contact.Since the reported condition of excessive pressure is not confirmed,the root cause for the same cannot be determined.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4) and no non-conformances were identified.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.Device history a manufacturing record evaluation was performed for the finished device (serial number : (b)(4) and no non-conformances were identified.Corrected data: unknown event date in 2019.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.

• Brand Name: 4176 FOOT PEDAL BOARD 4WAY
• Common Device Name: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8888072
• Report Number: 1221934-2019-57974
• Device Sequence Number: 2457186
• Product Code: HRX
• UDI-Device Identifier: 10886705017256
• UDI-Public: 10886705017256
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K954465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 284176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 10/28/2019; 11/04/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/28/2019; 11/11/2019
• Patient Sequence Number: 1