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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A distributor reported on behalf of the customer that the c2602 cusa excel 36khz straight handpiece does not pass the amplitude test and gives vibration alert when switched on and completed the wait period.If they also press the orange vibration foot pedal in run mode, there was no output and still gives vibration alert.They tried to change the tip but still there was no change.They were able to confirm the problem by checking another good handpiece which was working properly using the same cusa console.Additional information received on 11jun2020 stated that the customer has used the handpiece in two to three surgeries after installation.There was no known patient injury or delay in surgery.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h4, h6, h10.Device identifier: (b)(4).Product identifier: (b)(4).The device was not returned for evaluation therefore the failure analysis to identify root cause to the end user's experience could not be determined.The device history record (dhr) review showed no abnormalities related to the reported failure.The reported complaint was not confirmed.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The device was returned for evaluation: device history record (dhr) - the dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The reported complaint was confirmed.The defect was consistent with transducer delamination failures based on date of manufacture (2019), confirmed stroke and amplitude out of specification, and confirmed defective transducer.

• 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: 10261242
• MDR Text Key: 201543248
• Report Number: 3006697299-2020-00080
• 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,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: 09/16/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1