MAUDE Adverse Event Report: Bien-Air Surgery SA, Le Noirmont, Switzerland OSSEODUO foot pedal; Control unit foot pedal

Model Number	1600517
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After stepping on the foot pedal and releasing the foot, the motor kept on rotating.The magnet of the foot pedal came off its location.No patient was involved in the incident.
Additional Manufacturer Narrative
Event submitted in response to 483 dated (b)(6)2023.

• Brand Name: OSSEODUO foot pedal
• Common Device Name: Control unit foot pedal
• Manufacturer (Section D): Bien-Air Surgery SA, Le Noirmont, Switzerland; rue de l'ouest 2b; le noirmont, jura 2340 ; SZ 2340
• Manufacturer (Section G): Bien-Air Surgery SA; rue de l'ouest 2b; le noirmont, jura 2340 ; SZ 2340
• Manufacturer Contact: rivo razafintseheno ; rue de l'ouest 2b; le noirmont, jura 2340 ; SZ 2340
• MDR Report Key: 50927699
• Report Number: 3003800209-2024-00001
• Device Sequence Number: 21213745
• Product Code: HBC
• UDI-Device Identifier: 17630055505245
• UDI-Public: 17630055505245
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/30/2024

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: 1600517
• Device Catalogue Number: 1600517-001
• Date Returned to Manufacturer: 02/05/2019
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES#86419
• Patient Sequence Number: 1
• Patient Sex: Unknown