MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 36KHZ STRAIGHT HANDPIECE EACH1; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2602

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

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.

Event Description

A distributor reported that on an unspecified date, a c2602 excel 36khz straight handpiece each1 amplitude test did not pass and gave a vibration alert after switching on the unit and completing the wait period.Later in the run mode, if they press the orange vibration foot pedal, there was no output, and gave the vibration alert again.They tried changing the tip but no there was no change.They confirmed the problem by checking another known good 36khz handpiece on same cusa console and found that the cusa was working properly.There was no patient involved nor patient injury/death alleged on the device failure as the defect has been found at the distributor's service center while testing.

Manufacturer Narrative

The product was not returned so the evaluation was unable to be performed.Therefore, an investigation for cause was unable to be performed.The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The reported complaint was not confirmed.No root cause was determined.Udi: (b)(4).

Event Description

N/a.

• Brand Name: EXCEL 36KHZ STRAIGHT HANDPIECE EACH1
• 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: 8775691
• MDR Text Key: 150555139
• Report Number: 3006697299-2019-00075
• Device Sequence Number: 1
• Product Code: LBK
• Combination Product (y/n): N
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSA CONSOLE.; TIP.; CUSA CONSOLE; TIP