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

Catalog Number C2602

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Linked to mfg report number 3006697299-2020-00094.

Event Description

This is 2 of 2 reports.This is in regards to the 2nd incident.A customer reported that the c2602 excel 36khz straight handpiece worked during the first unspecified procedure on the operating room on (b)(6) 2020.The physician commented that the handpiece did not work on the last 15 minutes of it's procedure.Outside the operating room (or), another test was performed and handpiece seemed to work correctly, passing the vibration test and with good return.A procedure was performed and the handpiece worked for the whole surgery.After that procedure, on another day, a surgery was performed and with the handpiece assembled, device did not worked.Another test was performed with that handpiece outside the or and on the initial test, the handpiece seems to be working.After 2 to 3 minutes, the handpiece suddenly start sending vibration alerts and would not work again.Handpiece would give mixed results, sometimes working and others not working.Several tests were performed, some with positive results, other with the handpiece not vibrating.On the final test, handpiece did not vibrate.Before the last test without a patient, the handpiece was used on a procedure with negative results (as the device did not work- patient did not suffer any injury).Surgery delay was mostly due to the inability to use the cusa, longer surgery time.The device failed with vibration alert on most cases, almost no vibration or low vibration.Initial test did not pass.No patient injuries reported.

Event Description

N/a.

Manufacturer Narrative

Udi: (b)(4).C2602 cusa 36khz handpiece 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 from the evaluation.This complaint is consistent with transducer delamination failures based on the following: 1) date of manufacture 2019.2) confirmed low output.3) confirmed defective transducer.

• 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: 10400018
• MDR Text Key: 205477781
• Report Number: 3006697299-2020-00095
• 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

• 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: 08/18/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1