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

Catalog Number XXX-CUSA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Liver Damage/Dysfunction (1954); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.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 (b)(4) to (b)(4).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 (b)(4) and nc (b)(4)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)(6) director of regulatory programs, office of product evaluation and quality and (b)(6), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

Event Description

Experience and outcomes in living donor liver procurement using the water jet scalpel was published to clarify treatment outcomes of living donor liver procurement using the water jet scalpel (wjs).Methods: this single-center, retrospective cohort study included 40 living donors who underwent liver procurement from january 2014 to december 2018.One living donor who underwent posterior segmentectomy was excluded.Clinical data and outcomes after surgery for twenty wjs donors and nineteen cavitron ultrasonic surgical aspirator (cusa) donors were compared.Results: preoperative and excised graft data did not differ significantly between the wjs and cusa groups.Operation time (p = 0.025) and parenchymal transection time (p = 0.007) were significantly shorter in the wjs group.There was no difference between the groups in terms of short-term outcomes after surgery.Multivariate analysis revealed that wjs offered significant advantages over cusa in terms of shortening parenchymal transection time (p =0.017).Adverse events: no specific patient demographics were provided; 3 post hepatectomy liver failures and 1 bile leakage conclusions: living donor liver procurement using wjs contributes to shortening of parenchymal transection time while maintaining the same level of safety as when using cusa.

Manufacturer Narrative

The device was not returned so the evaluation was unable to be performed.Therefore, an investigation for cause was unable to be performed.No dhr review was possible as the required information was not reported.The complaint is not related to the device performance nor efficacy.Any allegations of a deficiency of performance of effectiveness of the cusa devices are expected to be communicated as complaints.No such complaints were received from the clinical site (hiroshima university) publishing these articles related to surgical outcomes.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); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• MDR Report Key: 10279589
• MDR Text Key: 205561734
• Report Number: 3006697299-2020-00039
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CUSA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1