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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not 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.

Event Description

It was reported that the c2602 cusa excel 36khz straight handpiece, after switching on the unit and completing the wait period, the self-test gets passed but it does not deliver the output power properly.During the 100% power setting, output varies and intermittently gives vibration alert.Attempts to change the tip and manifold tubing were made but no change was noted.Handpiece was checked with another known good 36khz handpiece on same cusa console and found cusa working properly without any problem.There was no patient involvement.Additional request for information has been made.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h4,h6, h10 device identifier:(b)(4) product identifier: (b)(4).Product was not returned so the evaluation was unable to be performed.The device history record (dhr) was reviewed and no anomalies that could be associated with the complaint incident was observed.Based on the reported failure "its not delivering output power properly" this complaint could be as a result of transducer delamination.However, without testing it is not possible to verify.An investigation for cause was unable to be performed.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) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• 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: 10275802
• MDR Text Key: 203116734
• Report Number: 3006697299-2020-00029
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

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: Other
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/29/2020
• 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