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

Model Number	284176
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Additional 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).
Event or Problem Description
It was reported by affiliate via mail that during shoulder scope; 4176 foot ped board 4way is not working.Account believes the prongs on the pump and foot pedal might be damaged and work intermittently.Foot pedal would work on and off but was able to complete case.Action taken to manage the issue: account has other pumps they can use but has requested replacement foot pedal and pump be sent in to replace.No ae to patient.No delay to the procedure.
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 has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.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: the complaint device is not being returned, our affiliate informed us that the device will be discarded, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device serial number (b)(6), and no non-conformances were identified.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: a manufacturing record evaluation was performed for the finished device serial number (b)(6), and no non-conformances were identified.

• Brand Name: 4176 FOOT PED 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: 10001023
• Report Number: 1221934-2020-01244
• Device Sequence Number: 19356070
• Product Code: HRX
• UDI-Device Identifier: 10886705017256
• UDI-Public: 10886705017256
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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 Model Number: 284176
• Device Catalogue Number: 284176
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 06/09/2020
• Patient Sequence Number: 1