MAUDE Adverse Event Report: RAYNHAM GENERATOR CIRCULAR FOOT PEDAL; ¿ELECTROSURGICAL¿

Catalog Number	901001CPED
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Insufficient Information (4580)
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 a generator circular foot pedal (id 901001cped) had a loose connection exposing the wires at the end of the foot pedal connector.No additional information available.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The generator circular foot pedal (id: 901001cpedsrl ) was returned for evaluation.Device history record (dhr): no anomalies occurred during the manufacturing process.Failure analysis: the foot pedal had a loose connection which was exposing wires at the end of the foot pedal.The complaint was confirmed upon receipt.The technician repaired the loose connection exposing the wires at the end of the foot pedal connector.Performed an evaluation and function test.Unit passes all test.Root cause analysis: the complaint was confirmed in the complaint investigation.Potential root causes include insufficient insulation.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.

• Brand Name: GENERATOR CIRCULAR FOOT PEDAL
• Common Device Name: ¿ELECTROSURGICAL¿
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17281337
• Report Number: 3014334038-2023-00106
• Device Sequence Number: 12082414
• Product Code: GEI
• UDI-Device Identifier: 10381780530374
• UDI-Public: 10381780530374
• Combination Product (Y/N): N
• PMA/510(K) Number: K183526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 901001CPED
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• 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