MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. UNKNOWN CUSA EXCEL; ULTRASONIC SURGICAL PRODUCTS

Catalog Number XXX-CUSA

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

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.Linked to mfg report no.: 3006697299-2020-00013; 3006697299-2020-00014; 3006697299-2020-00015.

Event Description

This is 1 of 4 reports.A sales representative reported in behalf of the customer that on (b)(6) 2020, the xxx-cusa unknown cusa excel was unable to provide any resection power during a meningioma resection procedure.The tumor was really fibrous and hard.They started the case with an excel console at 100 amplitude.As soon as the tip of the 36 khz handpiece was in contact with the tissue, amplitude dropped to 10%.There was some variation within the same on cycle but it was at 10% most of the time.They switched the console for an excel+ (blue top).The same problem occurred.They switched the handpiece for another 36 khz and the same problem occurred.It was really long and non-efficient as the handpiece was unable to provide any resection power.A delay in surgery was about 4 hours because of all the sterilization time, consumables delivery and slow resection caused by the first two handpieces.The case was recovered and the surgeon was able to resect the tumor in the end.Additional information received on 06feb2020 indicated that there was no adverse consequences to the patient due to the 4-hour delay.

Event Description

N/a.

Manufacturer Narrative

The product was not returned for evaluation.The device history record review was unable to be performed due to the lack of information.The failure analysis and root cause determination cannot be performed due to the product was not returned.The reported complaint is unconfirmed.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: UNKNOWN CUSA EXCEL
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• MDR Report Key: 10278252
• MDR Text Key: 204989438
• Report Number: 3006697299-2020-00016
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

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: XXX-CUSA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1