MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 23KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2600

Device Problems Output Problem (3005); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It has been reported that during inspection of the cusa excel 23khz handpiece (c2600), their was a crack on the neck of the handpiece, the tested power rating was only 20 to 30% and when running, the handpiece became very hot.There was no patient involvement or surgical delay, and no injury to the user was reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h4, h6, h10 the excel handpiece was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The complaint investigation (failure analysis) and determination of root cause is not possible.The 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 ¿crack on the handpiece neck, tested power rating is only 20-30%, very hot ¿ its possible this complaint was as a result of an irrigation system failure.Per customer comments "crack on the handpiece neck", the handpiece is also damaged.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.

Manufacturer Narrative

Excel 23khzhandpiece (c2600) 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.Failure analysis - the investigation of the unit confirmed the complaint as valid: fault confirmed, housing is cracked, cable tubing is clogged and burnt.The cable, housing and o-rings were replaced before calibrating the unit to manufacturer's specifications.Root cause - the reported complaint was confirmed.The housing was cracked, cable tubing was clogged and burnt.A corrective action is pending for cracked housing.

• Brand Name: CUSA EXCEL 23KHZ 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: 12952507
• MDR Text Key: 285708215
• Report Number: 3006697299-2021-00058
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C2600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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