MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2602

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 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.Linked to mfg report no.: 3006697299-2020-00014, 3006697299-2020-00015, 3006697299-2020-00016.

Event Description

This is 1 of 4 reports.A sales representative reported in behalf of the customer that on (b)(6) 2020, the c2602 cusa excel 36khz straight handpiece 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 (b)(6) 2020 indicated that there was no adverse consequences to the patient due to the 4-hour delay.

Manufacturer Narrative

Additional information: the device was returned to the manufacturer for physical evaluation.The device history record (dhr) was reviewed and no anomalies that could be associated with the complaint incident was observed.The complaint was verified as valid.The technician found that the handpiece had low power.The technician recommended that this handpiece be removed from service.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.

Event Description

N/a.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
• 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: 10278046
• MDR Text Key: 214798963
• Report Number: 3006697299-2020-00013
• 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: 03/05/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1