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 06/15/2020

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 3006697299-2020-00088 and 3006697299-2020-00090.

Event Description

This is 2 of 3 reports.A customer reported that the c2602 cusa excel 36khz straight handpiece had no vibration detected during a secondary test on (b)(6) 2020.Another cusa console was used but had the same result.There was no patient involvement.Additional information has been requested.

Manufacturer Narrative

Device identifier: (b)(4).Product identifier: (b)(4).The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The reported complaint could not be verified due as a product sample was not returned in order to verify the complaint.Based on the customer reported failure ¿ no vibration was detected¿ 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.

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: 10382083
• MDR Text Key: 204235065
• Report Number: 3006697299-2020-00089
• 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
• Treatment: CUSA CONSOLE.