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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A distributor reported on behalf of the customer that during skull surgery, the cusa excel 36khz straight handpiece (c2602) did not reach the necessary potency capacity.The unit was replaced with a another manufacturer's device.There was surgical delay of 1.5 hours with no reported patient injury.

Manufacturer Narrative

Additional information received indicated that the handpiece worked intermittently and its potency was no more than 10%, they selected 100% and it only reached 10% (amplitude).There was a common noise of the handpiece non-function alert was noted and the light on the console display.The excel 36khz straight handpiece (c2602) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.Based on the customer reported failure ¿piece does not reach the necessary potency capacity¿ its possible this complaint was as a result of transducer delamination.However, without testing it is not possible to verify.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

Failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.Based on this evaluation and the customer reported failure (¿piece does not reach the necessary potency capacity¿), it is most likely that this complaint was caused by transducer delamination.Root cause - from evaluation of the handpiece based on the reported failure (¿piece does not reach the necessary potency capacity¿), it is most likely that this complaint was caused by transducer delamination.This issue was addressed by an internal corrective action.Corrosion of the braze joint was found to be the root cause.Corrective action was taken to mitigate the onset of said corrosion by using an alternative braze filler alloy which does not contain zinc.A trial was completed which confirmed that the use of an alternative braze alloy does not affect the handpiece function, while it does mitigate the corrosion of the braze joint.In summary, this issue was resolved by a corrective action that was opened and implemented after the manufacture of this handpiece.No further investigation is required.

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
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12148116
• MDR Text Key: 268443904
• Report Number: 3006697299-2021-00023
• 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: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/10/2021
• Supplement Dates Manufacturer Received: 08/19/2021; 02/21/2022
• Supplement Dates FDA Received: 08/26/2021; 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1