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

Catalog Number C2602

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Event Description

A facility reported that after a period of normal operation of the cusa excel 36khz straight handpiece (c2602), the fragmentation indicator was not going high during operation.The device was in contact with the patient; however, there was no patient injury or death alleged.The event led to increased surgery time of 2-3 hours.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h4, h6, h10.The cusa excel 36khz straight handpiece (c2602) 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 evaluation verified the complaint as valid.The transducer was found to be twisted in the handpiece housing due to a user mistake; the torque base has not been used.The transducer is out of specifications.The transducer, housing and the o-rings will be exchanged and a full function test according to the manufacturer's guidelines must be performed.Root cause - the reported failure of ¿fragmentation issue¿ was confirmed by technician.The root cause of the issue was determined to overtorquing of the handpiece.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.Recommend to train customer per tech bulletin in correct torquing procedure.

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
• MDR Report Key: 11723862
• MDR Text Key: 247264418
• Report Number: 3006697299-2021-00015
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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: 04/08/2021
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1