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 07/01/2020

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 number 3006697299-2020-00089 and 3006697299-2020-00090.

Event Description

This is 1 of 3 of reports.A customer reported that the c2602 cusa excel 36khz straight handpiece was installed with the c5608 tip for a pediatric tumor extraction on (b)(6) 2020.After assembling the handpiece, the tip and the tubing did not pass the vibration test and vibration alarm was triggered.Another cusa console was used but had the same result.There was no problem with the console but the handpiece there was a delay in surgery (time unspecified) due to the inability to use the cusa.Surgery continued without the cusa.There was no patient injury or adverse consequence reported.

Event Description

Na.

Manufacturer Narrative

Device identifier: (b)(4).Product identifier: (b)(4).The device was not retuned for evaluation therefore the failure analysis and determination of root cause was not possible.Based on the customer reported failure ¿did not pass and vibration alarm was triggered¿ its possible this complaint was as a result of transducer delamination.However, without testing it is not possible to verify.Should the product be returned for analysis the complaint will be reopened and evaluation will be completed.The device history record (dhr) documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The reported complaint was not confirmed.

• 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: 10382048
• MDR Text Key: 204550969
• Report Number: 3006697299-2020-00088
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• 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?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1