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

Model Number C2600

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

Device history record - the dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The cusa excel handpiece (c2600) was returned for evaluation.Technician confirmed device passed all tests and meets specification.The complaint evaluation was unable to conclusively verify the complaint as valid.It has been recommended that customer be retrained on instructions for use (ifu) and correct use of handpiece.No further investigation is required.

Event Description

A facility reported that the cusa excel 23khz straight handpiece (c2600) unit was returned after repair and there was still malfunction in the ultrasound emission during laparoscopic hepatectomy surgery.The surgery was completed using ultracision.There was increase of surgery time of about 30 minutes; however, there was no injury to the patient.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The cusa excel 23khz straight handpiece (c2600) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the investigation of the unit verified the complaint as valid: the transducer found to be twisted in the handpiece housing.This is a user mistake, as the torque base was not used.The technician replaced the transducer and housing, then the device was retested and passed all tests.Root cause - the root cause of the issue was determined to be hp overtorquing.The handpiece overtorquing is caused by incorrect assembly and disassembly of the handpiece using the torque wrench.Overtorquing results in torque wrench misaligning the dot on the handpiece and the handpiece connector.A corrective action has been implemented for hp overtorquing per technical bulletin.The assembly and disassembly procedure of the handpiece using the torque wrench is outlined in the said technical bulletin.

• 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
• MDR Report Key: 11838241
• MDR Text Key: 260214411
• Report Number: 3006697299-2021-00018
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10381780039419
• UDI-Public: (01)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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2600
• Device Catalogue Number: C2600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1