MAUDE Adverse Event Report: LIVANOVA USA INC SUCTION SUMP WS 1/4 CONN; SUCTION WAND, SUCTION SUMP

Model Number	SU-29602
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Dhr of the complained device did not identify any problem.At the submission of the case, the customer has submitted a photographic evidence that confirms the claimed disconnection.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa received a report that, in two (2) events, the tip of the atra sump cannula could easily disconnect from the body of the canulla during the robotic procedure.One (1) unit is available for investigation, the other one (1) is contaminated.There was no patient involvement.
Additional Manufacturer Narrative
The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.Reviewing the database, other similar complaints were recorded from different customers but on different cannula lots in the last year.Investigation of the bond between the connector and tubing has indicated a strength limit related to the adhesive bond between these components due to the design of the connector.To increase the tip to tube pull strength, design changes of the connector are under investigation.The issue was addressed initiating a dedicated capa project.The risk is in the acceptable region.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: SUCTION SUMP WS 1/4 CONN
• Common Device Name: SUCTION WAND, SUCTION SUMP
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16129728
• Report Number: 1718850-2023-00021
• Device Sequence Number: 7673232
• Product Code: DTS
• UDI-Device Identifier: 00803622105913
• UDI-Public: (01)00803622105913(17)250531(10)2213000021(11)220511(240)SU-29602
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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 Expiration Date: 05/31/2025
• Device Model Number: SU-29602
• Device Lot Number: 2213000021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown