MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. CUSA CLARITY CONSOLE

Catalog Number C7000

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

It was reported that an error message "system error¿, 1208 ib_vacuum_pressure_low¿ was seen on the c7000 cusa clarity console.The unit was already primed and tested.The machine was restarted, and the error message persisted.The end of the contamination guard was removed from the canister and the unit itself was providing no suction.The device was not in contact with the patient.No patient injury nor delay in surgery reported.Additional information has been requested.

Manufacturer Narrative

The device was returned for evaluation.The technician found and replaced the broken aspiration elbow.The reported complaint was confirmed.

Event Description

N/a.

Manufacturer Narrative

Device identifier: (b)(4).Product identifier: (b)(6).The device was not returned for evaluation therefore the failure analysis to identify root cause could not be determined.The complaint could not be verified due as a product sample was not returned in order to verify the complaint.Based on the customer reported failure ¿ system error: 1208 ib_vacuum_pressure_low¿ (¿ its possible this complaint was as a result of a defective aspiration system or aspiration suction elbow.However, without testing it is not possible to verify.The device history record (dhr) was reviewed and no anomalies that could be associated with the complaint incident were observed.The reported complaint was not confirmed.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: CUSA CLARITY CONSOLE
• Type of Device: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• MDR Report Key: 10279237
• MDR Text Key: 206972234
• Report Number: 3006697299-2020-00024
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K182809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: C7000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 03/27/2020; 07/07/2020
• Supplement Dates FDA Received: 07/16/2020; 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1