MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 23KHZ STRAIGHT HANDPIECE EACH1; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number C2600

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/22/2023

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 facility reported that during a hepatectomy procedure, there was water leakage from the o-ring on the excel 23khz straight handpiece each1 (c2600).The suction function was working, but approximately 500ml of water is usually needed for irrigation, and 2l of water was consumed for this procedure.Nevertheless, this product was used to complete the procedure.An integra representative went to check the product, but it did not happen again using neither the brought-in demo machine nor the hospital-owned hand piece.According to the nurse,¿ o-ring was placed on the right position though, it would not stop leaking.A staff noticed that the suction port was diverging so he/she fixed it, but the situation did not improve".There was no patient injury and it is unknown if there was surgical delay.

Event Description

N/a.

Manufacturer Narrative

The excel 23khz straight handpiece (c2600) was returned for evaluation: device history record (dhr) - the dhr documentation was reviewed and no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Failure analysis - the investigation of the unit confirmed the complaint as valid: the handpiece (hp) is overtorqued, and as a result, a new transducer, coliform, cable, o-rings, and housing assembly were replaced.The hp was retested and passed all test to manufacturer's specification.Root cause - the root cause is confirmed as overtorquing due to incorrect assembly and disassembly of the hp by the customer using the torque wrench.This results in the torque wrench misaligning the dot on the hp and the hp connector.Corrective action is pending in relation to hp overtorquing.Trends will be monitored for this and similar issues.

• Brand Name: EXCEL 23KHZ STRAIGHT HANDPIECE EACH1
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: 18341044
• MDR Text Key: 331053808
• Report Number: 3006697299-2023-00128
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• 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