MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY FOOTSWITCH

Model Number	C7002
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that during the operation of the cusa clarity footswitch (c7002) when pressing the orange pedal the pedal stays in activation modus.They changed the foot pedal to another cusa clarity.The event led to increase surgery time for 5 minutes; however, there was no patient injury.
Additional Manufacturer Narrative
The cusa clarity footswitch (c7002 was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis -the investigation of the unit confirmed the complaint: the reported failure ¿when pressing footpedal, pedal stayed in activation¿ was confirmed.Device was scrapped, and footswitch was replaced with a new one.All functions are now working fine.Root cause - root cause was determined to be defective footswitch.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.

• Brand Name: CUSA CLARITY FOOTSWITCH
• Common Device Name: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13600087
• Report Number: 3006697299-2022-00025
• Device Sequence Number: 12220717
• Product Code: LFL
• UDI-Device Identifier: 10381780126256
• UDI-Public: (01)10381780126256
• Combination Product (Y/N): N
• PMA/510(K) Number: K161882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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: C7002
• Device Catalogue Number: C7002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown