MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK RPLC POWER SUPPLY; RPLC POWER - CERELINK

Catalog Number	826822
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a live pin of power supply country specific adaptor disconnected from its location.The pin has live 230 volts potential.The event led to less than 30 minutes surgical delay.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink power supply was returned for evaluation: dhr - no anomalies occurred during the manufacturing process.Failure analysis - visual inspection.Power supplies had live pins no longer connected to the blade adapter.The plastic surrounding the remaining pin showed signs of stress or deformation.This indicates the power supply when removed had an increased force load to the pin causing the plastic molding to yield.Root cause - the complaint was confirmed in the complaint investigation.The supplier evaluated and believes that the disconnection is due to the user pulling the blade out of the wall in which way it is acting like a lever and too much pressure is then applied to the blade.

• Brand Name: CERELINK RPLC POWER SUPPLY
• Common Device Name: RPLC POWER - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18344993
• Report Number: 3014334038-2023-00193
• Device Sequence Number: 6222421
• Product Code: GWM
• UDI-Device Identifier: 10886704081098
• UDI-Public: 10886704081098
• Combination Product (Y/N): N
• PMA/510(K) Number: K210993
• 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): 05/24/2024

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 Catalogue Number: 826822
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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