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

Catalog Number C2600

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

This is 2 of 3 reports linked to mfg report numbers 3006697299-2023-00089 and 3006697299-2023-00091.A facility reported that during use of the cusa excel handpiece (unknown catalog#), the cusaexcel9 console emitted a "cooling alarm." additional information was received as follows: when was the issue discovered (before, during, after surgery)? answer : during was the patient already under anesthesia? answer : yes.Was the patient injured? if yes, please describe injury and treatment.Answer : no.Did the event lead to increase surgery time? if yes, for how long? answer : maybe 30 minutes, they had to change the handpiece two times.The third and last handpiece gave no problems.How did the medical staff finish the procedure (using replacement unit)? answer : see above answer.

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

N/a.

Manufacturer Narrative

Updated fields: d1, d4, g3, g6, h2, h3, h10.Additional information received; therefore, catalog# and brand name have been updated.

Event Description

N/a.

Manufacturer Narrative

The cusa excel 23khz straight handpiece (c2600) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Failure analysis - evaluation found the transducer to be twisted in the handpiece (hp) housing.The coil form is defective (shield is broken) and the housing and all o-rings of the coil form needed to be exchanged.To resolve the issue, the above defective parts have been replaced, and a full function test including calibration and safety test according to the manufacturer guidelines was performed.Root cause - the root cause is confirmed as handpiece overtorqued due to incorrect assembly and disassembly of the handpiece by the customer using the torque wrench which results in torque wrench misaligning the dot on the handpiece and the handpiece connector.A corrective and preventative action (capa) has been raised to address this issue.

• 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: 17624221
• MDR Text Key: 321959505
• Report Number: 3006697299-2023-00090
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10381780039419
• UDI-Public: 10381780039419
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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