MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 23KHZ LAPAROSCOPIC TIP ELT; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C4604ELT

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

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

A facility reported that during a hepatectomy procedure, it was found that the flue of the cusa excel was too short, and the irrigation fluid leaked.The flue was changed to a new one and the procedure was completed.Subsequent information indicates aspiration fluid could not be sucked up and the gantry was flooded.There was a surgical delay of 30 minutes with no adverse consequence to the patient.

Manufacturer Narrative

The returned units were visually evaluated and measured.The length of the shortest flue measured approximately 11.20 inches and the longest one 11.70 inches.The device history record (dhr) of the lot involved in the incident could not be reviewed because the lot number was not provided.However, with the catalog information provided (c4604elt), it was possible to identify the drawing corresponding to the flue of this product.According to the drawing, the length specification is 11.70 ± 0.03 inches.The length of shortest flue measured approximately 11.20 inches and the longest one 11.70 inches.The length specification of the existing flues used at integra was reviewed and there is no other flue with a length dimension of approximately 11.2 inches.Integra in receives the flues with a certification of compliance from the supplier.In addition, the supplier of the flues was contacted and confirmed that they do not manufacture flues with a length specification of 11.20 inches neither for integra nor for other customer.The integra quality system was reviewed within the past 24 months, but there are no events or complaints related to the short defect reported in the laparoscopic flue component.Based on the investigation results, any relationship with the packaging processes at integra and the manufacturing process in the flue¿s supplier process with the reported condition were ruled out.Therefore, it is unknown the origin of the shortest flue.

Event Description

N/a.

• Brand Name: CUSA EXCEL 23KHZ LAPAROSCOPIC TIP ELT
• 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: 10880886
• MDR Text Key: 217674716
• Report Number: 3006697299-2020-00122
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C4604ELT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1